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

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GBT440
Sponsored by
Global Blood Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ICON Early Phase Services, LLC Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Sequence 1

Treatment Sequence 2

Arm Description

Treatment A with one 300 mg capsule (high-strength) of GBT440 administered in a fasted state (test) in dosing Period 1 followed by Treatment B with 300 mg (3 × 100 mg) capsules (low-strength) of GBT440 administered in a fasted state (reference) in dosing Period 2.

Treatment B with 300 mg (3 × 100 mg) capsules (low-strength) of GBT440 administered in a fasted state (reference) in dosing Period 1 followed by Treatment A with one 300 mg capsule (high-strength) of GBT440 administered in a fasted state (test) in dosing Period 2.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Maximum observed concentration (Cmax) of GBT440 in whole blood
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
Pharmacokinetics (PK): AUC from time 0 extrapolated to infinity (AUCinf) of GBT440 in whole blood

Secondary Outcome Measures

Pharmacokinetics (PK): The time that Cmax was observed (tmax) of GBT440 in whole blood
Pharmacokinetics (PK): Terminal elimination half-life (t½) of GBT440 in whole blood
Pharmacokinetics (PK): Apparent oral clearance (CL/F) of GBT440 in whole blood
Pharmacokinetics (PK): Apparent volume of distribution during the terminal phase (Vz/F) of GBT440 in whole blood

Full Information

First Posted
September 30, 2015
Last Updated
April 10, 2017
Sponsor
Global Blood Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02567695
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Global Blood Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Sequence 1
Arm Type
Experimental
Arm Description
Treatment A with one 300 mg capsule (high-strength) of GBT440 administered in a fasted state (test) in dosing Period 1 followed by Treatment B with 300 mg (3 × 100 mg) capsules (low-strength) of GBT440 administered in a fasted state (reference) in dosing Period 2.
Arm Title
Treatment Sequence 2
Arm Type
Experimental
Arm Description
Treatment B with 300 mg (3 × 100 mg) capsules (low-strength) of GBT440 administered in a fasted state (reference) in dosing Period 1 followed by Treatment A with one 300 mg capsule (high-strength) of GBT440 administered in a fasted state (test) in dosing Period 2.
Intervention Type
Drug
Intervention Name(s)
GBT440
Intervention Description
Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum observed concentration (Cmax) of GBT440 in whole blood
Time Frame
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
Title
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
Time Frame
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
Title
Pharmacokinetics (PK): AUC from time 0 extrapolated to infinity (AUCinf) of GBT440 in whole blood
Time Frame
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 Outcome Measure Information:
Title
Pharmacokinetics (PK): The time that Cmax was observed (tmax) of GBT440 in whole blood
Time Frame
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
Title
Pharmacokinetics (PK): Terminal elimination half-life (t½) of GBT440 in whole blood
Time Frame
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
Title
Pharmacokinetics (PK): Apparent oral clearance (CL/F) of GBT440 in whole blood
Time Frame
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
Title
Pharmacokinetics (PK): Apparent volume of distribution during the terminal phase (Vz/F) of GBT440 in whole blood
Time Frame
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 Pre-specified Outcome Measures:
Title
Treatment-emergent adverse events (TEAEs) and serious adverse events
Time Frame
Baseline to Period 2 Day 28
Title
Changes in clinical laboratory results
Time Frame
Baseline to Period 2 Day 28
Title
Changes in physical examination findings
Time Frame
Baseline to Period 2 Day 28
Title
Changes in vital signs
Time Frame
Baseline to Period 2 Day 28
Title
Changes in electrocardiograms (ECGs)
Time Frame
Baseline to Period 2 Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Washington, PhD
Organizational Affiliation
Global Blood Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
ICON Early Phase Services, LLC Clinical Research Unit
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

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

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