Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02206295
Other study ID # AC-065-108
Secondary ID
Status Completed
Phase Phase 1
First received July 30, 2014
Last updated July 30, 2014
Start date September 2012
Est. completion date December 2012

Study information

Verified date July 2014
Source Actelion
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The primary aim of this study is to demonstrate bioequivalence in the rate and extent of absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of 1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8 film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects following a multiple-dose up-titration scheme.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Signed informed consent in the local language prior to any study-mandated procedure.

- Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.

- No clinically significant findings on the physical examination at Screening.

- Body mass index of 18.0 to 30.0 kg/m^2 (inclusive) at Screening.

- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute (all inclusive), measured at Screening.

- 12-lead electrocardiogram without clinically relevant abnormalities, measured at Screening.

- Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at Screening.

- Negative results from urine drug screen and alcohol breath test at Screening.

- Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

- Known allergic reactions or hypersensitivity to selexipag or any excipient of the drug formulation used in this study.

- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of selexipag.

- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.

- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).

- Treatment with selexipag or another investigational drug within 1 month prior to Screening or 5 half-lives, whichever is longer.

- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.

- Excessive caffeine consumption at Screening.

- Smoking within 3 months prior to Screening and inability to refrain from smoking during the course of the study.

- Previous treatment with any prescribed medications (including vaccines) or over-the-counter medications within 2 weeks prior to first study drug administration.

- Loss of 500 mL or more of blood within 3 months prior to Screening.

- Positive results from the hepatitis serology (hepatitis B antigen and hepatitis C antibodies), except for vaccinated subjects or subjects with past but resolved hepatitis, at Screening.

- Positive results from the human immunodeficiency virus serology at Screening.

- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

- Legal incapacity or limited legal capacity at Screening.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
selexipag


Locations

Country Name City State
Netherlands QPS Groningen

Sponsors (1)

Lead Sponsor Collaborator
Actelion

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration-time curve (AUCt) for selexipag Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 µg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. AUCt will be calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification during one dosing interval. 23 days No
Primary Maximum plasma concentration at steady state (Cmax,ss) for selexipag Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 µg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of selexipag will be used to directly obtain Cmax,ss. 23 days No
Secondary Area under the plasma concentration-time curve (AUCt) for ACT-333679 Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 µg selexipag b.i.d. during Treatments A and B. ACT-333679 will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. AUCt will be calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification during one dosing interval. 23 days No
Secondary Maximum plasma concentration at steady state (Cmax,ss) for ACT-333679 Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 µg selexipag b.i.d. during Treatments A and B. ACT-333679 will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of ACT-333679 will be used to directly obtain Cmax,ss. 23 days No
Secondary Time to reach maximum plasma concentration at steady state (tmax,ss) for selexipag Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 µg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of selexipag will be used to directly obtain tmax,ss. 23 days No
Secondary Trough plasma concentration at the end of one dose interval (Ctrough) for selexipag Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 µg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of selexipag will be used to directly obtain Ctrough. 23 days No
Secondary Trough plasma concentration at the end of one dose interval (Ctrough) for ACT-333679 Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 µg selexipag b.i.d. during Treatments A and B. ACT-333679 will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of ACT-333679 will be used to directly obtain Ctrough. 23 days No
Secondary Trough plasma concentration at steady state (Ctrough,ss) for selexipag Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 µg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of selexipag will be used to directly obtain Ctrough,ss. 23 days No
Secondary Trough plasma concentration (Ctrough,ss) for ACT-333679 Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 µg selexipag b.i.d. during Treatments A and B. ACT-333679 will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of ACT-333679 will be used to directly obtain Ctrough,ss. 23 days No
Secondary Change in systolic blood pressure from baseline up to end of study Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand). up to 28 days Yes
Secondary Change in diastolic blood pressure from baseline up to end of study Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand). up to 28 days Yes
Secondary Change in pulse rate from baseline up to end of study Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand). up to 28 days Yes
Secondary Change in body weight from baseline up to end of study Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand). up to 28 days Yes
Secondary Change in heart rate from baseline up to end of study Heart rate will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period. up to 28 days Yes
Secondary Change in PQ/PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) from baseline up to end of study PQ/PR interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period. up to 28 days Yes
Secondary Change in QRS interval (time interval from the beginning of the Q wave to the end of the S wave) from baseline up to end of study QRS interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period. up to 28 days Yes
Secondary Change in QT interval (time interval from beginning of the Q wave until end of the T wave) from baseline up to end of study QT interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period. up to 28 days Yes
Secondary Change in QTcB interval (time interval from beginning of the Q wave until end of the T wave, according to Bazett's correction) from baseline up to end of study QT interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period. QTcB will be calculated according to the following formula (QTcB = QT/RR^0.5 where RR is 60/heart rate). up to 28 days Yes
Secondary Change in QTcF interval (time interval from beginning of the Q wave until end of the T wave, according to Fridericia's correction) from baseline up to end of study QT interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period. QTcF will be calculated according to the following formula (QTcF = QT/RR^0.33 where RR is 60/heart rate). up to 28 days Yes
Secondary Number of treatment-emergent electrocardiogram abnormalities from baseline up to end of study Electrocardiogram abnormalities will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period. up to 28 days Yes
Secondary Number of participants with adverse events leading to discontinuation of study treatment Adverse events will be considered as any adverse change from the subject's baseline condition that occurred during the course of the study. The subjects will be required to report any adverse events spontaneously. In addition, each subject will be assessed by the investigator at any measurement timepoint as well as at the end of observation and whenever necessary as deemed by the investigator. up to 28 days Yes
See also
  Status Clinical Trial Phase
Completed NCT03705533 - Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State Phase 1
Completed NCT04938856 - Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions Phase 1
Completed NCT03646331 - Bioequivalence of Imeglimin Tablet Formulations Phase 1
Completed NCT04564456 - A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05197517 - Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition Phase 1
Completed NCT03702894 - Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions Phase 1
Withdrawn NCT02894515 - Bioequivalence Study of Idalopirdine in Healthy Subjects Phase 1
Completed NCT03018015 - Ibuprofen Bioavailability Trial With Oral Single Dose Administration. Phase 1
Completed NCT01331993 - A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation Phase 1
Completed NCT01260805 - A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers. Phase 1
Recruiting NCT06066112 - Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body Phase 1
Completed NCT05477810 - Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions Early Phase 1
Completed NCT04546256 - A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05083325 - Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product Phase 1
Completed NCT05061901 - Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions Phase 1
Recruiting NCT04138888 - A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions Phase 1
Completed NCT05145621 - Oral Bio-equivalence Study Phase 1
Completed NCT06124560 - Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions. Phase 1
Completed NCT03340753 - Bioavailability of KBP-5074 Tablet vs Capsule Formulations Phase 1
Completed NCT04230070 - Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product Phase 1