NCT02567682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

September 23, 2015

Last Update Submit

April 10, 2017

Conditions

Sickle Cell Disease

Keywords

anemia, sickle cell

Outcome Measures

Primary Outcomes (3)

  • Peak plasma concentration(Cmax) for caffeine, S warfarin, omeprazole, and midazolam in plasma

    0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

  • Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUCt) for caffeine, S warfarin, omeprazole, and midazolam

    0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

  • Area under the plasma concentration time curve from time 0 extrapolated to infinity (AUCinf) for caffeine, S warfarin, omeprazole, and midazolam

    0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

Secondary Outcomes (14)

  • The time that Cmax was observed (tmax) for caffeine, S warfarin, omeprazole, and midazolam in plasma

    0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

  • Terminal elimination half-life (t½) for caffeine, S warfarin, omeprazole, and midazolam in plasma

    0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

  • Cmax for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma

    0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

  • tmax, for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma

    0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

  • AUCt for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma

    0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

  • +9 more secondary outcomes

Other Outcomes (6)

  • Treatment-emergent adverse events (TEAEs) and serious adverse events

    Baseline to Period 2 Day 25

  • Change in clinical laboratory tests

    Baseline to Period 2 Day 25

  • Change in physical examination findings

    Baseline to Period 2 Day 25

  • +3 more other outcomes

Study Arms (1)

Fixed sequence, 2-periods

EXPERIMENTAL

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

Drug: GBT440

Interventions

GBT440DRUG

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

Fixed sequence, 2-periods

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON Early Phase Services, LLC Clinical Research Unit

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

voxelotor

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Carla Washington, PhD

    Global Blood Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

October 5, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

US(1)