A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects

Sickle Cell Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567695
• Other study ID #: GBT440-004
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2015
• Last updated: April 10, 2017
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2015
• Source: Global Blood Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• GBT440
Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)

Locations

Country	Name	City	State
United States	ICON Early Phase Services, LLC Clinical Research Unit	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Global Blood Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment-emergent adverse events (TEAEs) and serious adverse events		Baseline to Period 2 Day 28
Other	Changes in clinical laboratory results		Baseline to Period 2 Day 28
Other	Changes in physical examination findings		Baseline to Period 2 Day 28
Other	Changes in vital signs		Baseline to Period 2 Day 28
Other	Changes in electrocardiograms (ECGs)		Baseline to Period 2 Day 28
Primary	Pharmacokinetics (PK): Maximum observed concentration (Cmax) of GBT440 in whole blood		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
Primary	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		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
Primary	Pharmacokinetics (PK): AUC from time 0 extrapolated to infinity (AUCinf) of GBT440 in whole blood		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	Pharmacokinetics (PK): The time that Cmax was observed (tmax) of GBT440 in whole blood		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	Pharmacokinetics (PK): Terminal elimination half-life (t½) of GBT440 in whole blood		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	Pharmacokinetics (PK): Apparent oral clearance (CL/F) of GBT440 in whole blood		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	Pharmacokinetics (PK): Apparent volume of distribution during the terminal phase (Vz/F) of GBT440 in whole blood		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