Healthy Subjects Clinical Trial
Official title:
A Single-center, Open-label, Two-period, Two-treatment, Crossover, Single-dose Study in Healthy Female and Male Subjects to Assess the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of ACT-129968
Verified date | July 2018 |
Source | Idorsia Pharmaceuticals Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To explore the pharmacokinetics (PK) of a single dose of two different formulations of ACT-129968, i.e., tablet versus capsule and to evaluate the safety and tolerability of a single dose of two different formulations of ACT-129968, i.e., tablet versus capsule.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 1, 2011 |
Est. primary completion date | July 1, 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent in the local language prior to any study-mandated procedure. - Women must have - a negative serum pregnancy test at screening and - a negative urine pregnancy test pre-dose on Day-1 of each treatment period. - Women of childbearing potential must consistently and correctly use (from screening, during the entire study, and for at least 28 days after last study drug intake) a reliable method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner. Women not of childbearing potential are defined as post-menopausal (i.e., spontaneous amenorrhea for at least 1 year without an alternative medical cause) or surgically or naturally sterile. - No clinically significant findings on the physical examination at screening. - Body mass index (BMI) of 18.0 to 28.0 kg/m^2 (inclusive) at screening. - Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate (PR) 45-90 bpm (inclusive), measured on the dominant arm (dominant arm = writing arm) after 5 minutes in the supine position at screening. - 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 minutes in the supine position 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 breath alcohol test at screening and on admission to the unit (Day-1) in Period 1 and Period 2. - Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study. Exclusion Criteria: - Pregnant or lactating women. - Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s). - 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 the study drug (appendectomy and herniotomy allowed, cholecystectomy not allowed). - Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions. - History or clinical evidence of allergic rhinitis or asthma. - 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). - Previous exposure to the study medication. - Treatment with another investigational drug within 3 months prior to screening or participation in more than four investigational drug studies within 1 year prior to screening. - History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening. - Excessive caffeine consumption, defined as 800 mg per day at screening. - Alcohol consumption of > 21 units/week or > 3 units/day. - Smoking within 3 months prior to screening. - Previous treatment with any prescribed or over-the-counter medications (including herbal medicines such as St John's Wort) within 2 weeks prior to first study drug administration. - Loss of 250 mL or more of blood within 3 months prior to screening. - Positive results from the hepatitis serology (Hepatitis B surface antigen and anti-hepatitis C virus), except for vaccinated subjects or subjects with past but resolved hepatitis (defined as positive finding for antibodies but negative findings for antigens), 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. |
Country | Name | City | State |
---|---|---|---|
Germany | PHAROS GmbH Clinical Research | Ulm |
Lead Sponsor | Collaborator |
---|---|
Idorsia Pharmaceuticals Ltd. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The area under the plasma concentration-time curve from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t). | The plasma PK parameters for ACT-129968 will be derived by non-compartmental analysis of the plasma concentrationtime profiles. | Up to 48 h in each treatment period (1 and 2) | |
Primary | The area under the plasma concentration-time curve from zero to infinity (AUC0-infinity). | The plasma PK parameters for ACT-129968 will be derived by non-compartmental analysis of the plasma concentrationtime profiles. | Up to 48 h in each treatment period (1 and 2) | |
Primary | The maximum plasma concentration (Cmax) | The plasma PK parameters for ACT-129968 will be derived by non-compartmental analysis of the plasma concentrationtime profiles. | Up to 48 h in each treatment period (1 and 2) | |
Primary | The time to reach maximum plasma concentration (tmax) | The plasma PK parameters for ACT-129968 will be derived by non-compartmental analysis of the plasma concentrationtime profiles. | Up to 48 h in each treatment period (1 and 2) | |
Primary | The terminal elimination half-life (t½) | The plasma PK parameters for ACT-129968 will be derived by non-compartmental analysis of the plasma concentrationtime profiles. | Up to 48 h in each treatment period (1 and 2) | |
Secondary | Change from baseline to each time point of measurement during each treatment period and to EOS in supine blood pressure | mmHg | Up to 13 days | |
Secondary | Change from baseline to each time point of measurement during each treatment period and to EOS in pulse rate | bpm | Up to 13 days | |
Secondary | Body weight at baseline and end of study visit | Up to 13 days | ||
Secondary | Change from baseline to EOS for hematology | Up to 13 days | ||
Secondary | Change from baseline to EOS for clinical chemistry | Up to 13 days | ||
Secondary | Change from baseline to EOS for pregnancy serum test | Up to 13 days | ||
Secondary | Change from baseline to EOS for virus serology | Up to 13 days | ||
Secondary | Change from baseline to each time point of measurement during each treatment period and to EOS in ECG variables | ECG variables are to be recorded at rest using a standard 12-lead ECG | Up to 13 days | |
Secondary | Number of patients with treatment-emergent ECG abnormalities for each treatment period | from study drug administration on Day 1 up to 48 hours post-dose | ||
Secondary | Number of patients with treatment-emergent physical examination abnormalities at EOS | Up to 13 days | ||
Secondary | Number of patients with treatment-emergent AEs and SAEs for each treatment period | from study drug administration on Day 1 up to 48 hours post-dose | ||
Secondary | Number of patients with AEs leading to premature discontinuation of study drug | Entire duration of study |
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