Clinical trial NCT02567695: A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects
Official title: A Phase 1, Single-Dose, Open-Label, Randomized, Two-Period Crossover Study to Evaluate the Relative Bioavailability of GBT440 300 mg Administered as Capsule Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sickle Cell Disease
Lead sponsor: Global Blood Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100 mg) capsule formulation in healthy fasted subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening
* Male subjects agree to use contraception
* Willing and able to give written informed consent

Exclusion Criteria:

* Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal,hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of hypersensitivity or allergy to drugs, foods, or other substances
* History or presence of abnormal electrocardiogram or hypertension
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 1 year of screening
* Participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum observed concentration (Cmax) of GBT440 in whole blood
timeFrame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
measure: Pharmacokinetics (PK): Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUCt) of GBT440 in whole blood
timeFrame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
measure: Pharmacokinetics (PK): AUC from time 0 extrapolated to infinity (AUCinf) of GBT440 in whole blood
timeFrame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
Secondary outcomes:
measure: Pharmacokinetics (PK): The time that Cmax was observed (tmax) of GBT440 in whole blood
timeFrame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
measure: Pharmacokinetics (PK): Terminal elimination half-life (t½) of GBT440 in whole blood
timeFrame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
measure: Pharmacokinetics (PK): Apparent oral clearance (CL/F) of GBT440 in whole blood
timeFrame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
measure: Pharmacokinetics (PK): Apparent volume of distribution during the terminal phase (Vz/F) of GBT440 in whole blood
timeFrame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
Other outcomes:
measure: Treatment-emergent adverse events (TEAEs) and serious adverse events
timeFrame: Baseline to Period 2 Day 28
measure: Changes in clinical laboratory results
timeFrame: Baseline to Period 2 Day 28
measure: Changes in physical examination findings
timeFrame: Baseline to Period 2 Day 28
measure: Changes in vital signs
timeFrame: Baseline to Period 2 Day 28
measure: Changes in electrocardiograms (ECGs)
timeFrame: Baseline to Period 2 Day 28
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Services, LLC Clinical Research Unit
state: Texas
Study officials:
affiliation: Global Blood Therapeutics
name: Carla Washington, PhD
role: STUDY_DIRECTOR
References: