Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01686217
Other study ID # 015K-CL-PK51
Secondary ID
Status Completed
Phase Phase 1
First received September 6, 2012
Last updated August 31, 2015
Start date June 2012
Est. completion date July 2012

Study information

Verified date August 2015
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release strengths in healthy volunteers.


Description:

Study involves 3 parallel groups. Subjects in each group will receive 3 single-dose treatments with a washout period of at least 7 days separating the dosing between two consecutive treatments. Dosing conditions include both fed and fasted conditions.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- The subject must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2, inclusive at Screening

- If female, the subject is surgically sterile (with documentation provided by a healthcare professional), or is post-menopausal (defined as at least 2 years since last regular menstrual cycle and confirmatory follicle stimulating hormone (FSH) level of = 30 U/L at screening) and the subject is not pregnant as documented by a negative serum pregnancy test at Screening and Day -1 and is not lactating

- If male, the subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional) or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method during the study and until 90 days after the last dose of study drug administration

- Male subject must agree to not donate sperm during the study and until 90 days after last dose of study drug administration

- The subject's 12-lead electrocardiogram (ECG) is normal at Screening and Day -1 of initial treatment period or, if abnormal, the abnormality is not clinically significant as determined by the Investigator

- The subject's clinical laboratory test results at Screening and Day -1 are within normal limits unless the Investigator considers the abnormality to be "not clinically significant"

- The subject is medically healthy, with no clinically significant medical history or abnormalities observed upon physical examination as determined by the Investigator

- The subject is willing and able to comply with the study requirements

- The subject must be capable of swallowing multiple tablets

- The subject is able to consume the FDA high fat breakfast within 30 minutes

Exclusion Criteria:

- The subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition that, in the Investigator's opinion, would preclude participation in the study

- The subject has had major GI surgery (such as colectomy, cholecystectomy, etc) which may inhibit the absorption and/or metabolism of study drug

- The subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to Screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)

- The subject has a positive test for alcohol or drugs of abuse at Screening or Day -1

- The subject has a positive cotinine test at Screening or Day -1

- The subject has had treatment with prescription, non-prescription or complementary and alternative medicines (CAM) within 14 days prior to Day -1 (of initial treatment period) with the exception of stable hormone replacement therapy (HRT) and/or occasional use of acetaminophen (up to a maximum of 2 g/day)

- The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to Day -1

- The subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody at Screening

- The subject has a history of the human immunodeficiency virus (HIV) antibody

- The subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOTĀ® test at Screening

- The subject received any vaccine within 60 days prior to study drug administration

- The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration

- The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1

- The subject has an absolute neutrophil count (ANC) < 2500 cells/mm3 or a CPK > 1.5x upper limit of normal at Screening and Day -1 of initial treatment period

- The subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to Screening

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

Drug:
ASP015K ER
oral extended release (ER) at three dosing levels
ASP015K IR
oral immediate release (IR)

Locations

Country Name City State
United States Parexel International Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic (PK) for ASP015K (in plasma): Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf) Day 1-4 of each of 3 dosing periods No
Primary PK for ASP015K (in plasma): AUC from time of dosing to last quantifiable concentration (AUClast) Days 1-4 of each of 3 dosing periods No
Primary PK for ASP015K (in plasma): Maximum concentration (Cmax) Days 1-4 of each of 3 dosing periods No
Secondary PK profile for ASP015K (in plasma): tmax , t1/2 , Vz /F, and CL/F Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ), apparent volume of distribution (Vz /F), apparent body clearance after oral dosing (CL/F) Day 1-4 of each of 3 dosing periods No
Secondary PK profile for metabolites (in plasma): Cmax, AUClast, and AUCinf, tmax,t1/2 Day 1-4 of each of 3 dosing periods No
See also
  Status Clinical Trial Phase
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1