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Completed

NCT Number: NCT02567682

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, LLC Clinical Research Unit

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GBT440

Drug

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

Primary outcomes

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

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

  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

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

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

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

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

  6. AUCinf for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma

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

  7. t1/2 for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma

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

  8. Ratio of metabolite to parent Cmax corrected for molecular weight (Cmax M/P) for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma

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

  9. Ratio of metabolite to parent AUCt corrected for molecular weight (AUCt M/P)for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma

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

  10. Ratio of metabolite to parent AUCinf corrected for molecular weight (AUCinf M/P) for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma

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

  11. Cmax for GBT440 in whole blood and plasma

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

  12. tmax for GBT440 in whole blood and plasma

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

  13. AUC from time 0 to 24 hours (AUC0-24) (Days 4 and 7) for GBT440 in whole blood and plasma

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

  14. t1/2 (Day7) for GBT440 in whole blood and plasma

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

Other outcomes

  1. Treatment-emergent adverse events (TEAEs) and serious adverse events

    Time frame: Baseline to Period 2 Day 25

  2. Change in clinical laboratory tests

    Time frame: Baseline to Period 2 Day 25

  3. Change in physical examination findings

    Time frame: Baseline to Period 2 Day 25

  4. Change in vital signs

    Time frame: Baseline to Period 2 Day 25

  5. Change in pulse oximetry findings

    Time frame: Baseline to Period 2 Day 25

  6. Change in electrocardiograms (ECGs)

    Time frame: Baseline to Period 2 Day 25

Sponsors and collaborators

Lead sponsor

Global Blood Therapeutics

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of GBT440 on the Pharmacokinetics of Probe Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4 in Healthy Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2015
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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