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

• ClinicalTrials.gov Identifier: NCT02567695
• Recruitment Status: Completed
• First Posted: October 5, 2015
• Last Update Posted: April 12, 2017
• Sponsor: Global Blood Therapeutics
• Information provided by (Responsible Party): Global Blood Therapeutics

Tracking Information

• First Submitted Date: September 30, 2015
• First Posted Date: October 5, 2015
• Last Update Posted Date: April 12, 2017
• Actual Study Start Date: September 2015
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 1, 2015)

• 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 ]
• 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 ]
• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 1, 2015)

• 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 ]
• 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 ]
• 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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 1, 2015)

• Treatment-emergent adverse events (TEAEs) and serious adverse events [ Time Frame: Baseline to Period 2 Day 28 ]
• Changes in clinical laboratory results [ Time Frame: Baseline to Period 2 Day 28 ]
• Changes in physical examination findings [ Time Frame: Baseline to Period 2 Day 28 ]
• Changes in vital signs [ Time Frame: Baseline to Period 2 Day 28 ]
• Changes in electrocardiograms (ECGs) [ Time Frame: Baseline to Period 2 Day 28 ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sickle Cell Disease

Intervention

Drug: GBT440

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

Study Arms

• Experimental: Treatment Sequence 1
  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.
  Intervention: Drug: GBT440
• Experimental: Treatment Sequence 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.
  Intervention: Drug: GBT440

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 1, 2015): 26
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02567695
• Other Study ID Numbers: GBT440-004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Global Blood Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Global Blood Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Carla Washington, PhD; Global Blood Therapeutics

• PRS Account: Global Blood Therapeutics
• Verification Date: September 2015