Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects

NCT ID: NCT02567682

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-05-31

Brief Summary

The purpose of this study to evaluate the effect of concomitant administration of GBT440 on caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.

Conditions

Sickle Cell Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fixed sequence, 2-periods

An open-label, fixed sequence, 2-period drug interaction study Period 1 Treatment A: Single dose of drug cocktail on Day 1 Period 2 Treatment B: GBT440 on Days 1 through 3 and Treatment C: Single dose of drug cocktail on Day 4 and GBT440 on Days 4 through 7

Group Type: EXPERIMENTAL

GBT440

Intervention Type: DRUG

GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam

Interventions

GBT440

GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 55 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Global Blood Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carla Washington, PhD

Role: STUDY_DIRECTOR

Global Blood Therapeutics

Locations

ICON Early Phase Services, LLC Clinical Research Unit

San Antonio, Texas, United States

Countries

United States

Other Identifiers

GBT440-003

Identifier Type: -

Identifier Source: org_study_id