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Completed

NCT Number: NCT02497924

A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects

This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440.

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Key information

Conditions

Anemia, Sickle Cell Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital 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

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Early Clinical Services

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy; non-smoking male; 18 to 55 years old, inclusive
  • Weighs at least 50 kg and not more than 110 kg
  • Agrees 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 stomach or intestinal surgery that would potentially alter drug absorption
  • History of hypersensitivity or allergy to drugs, foods, or other substances
  • History or presence of abnormal electrocardiogram
  • Exposure to significant radiation or participated in more than 1 other radiolabeled study drug trial within 12 months 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 single dose of [C14] GBT440 oral suspension

Primary outcomes

  1. Area under the whole blood and plasma concentration versus time curve (AUC)

    Time frame: 0 to 648 hours post dose

  2. Peak whole blood and plasma concentration (Cmax)

    Time frame: 0 to 168 hours post dose

  3. Time to peak whole blood and plasma concentration (Tmax)

    Time frame: 0 to 168 hours post dose

  4. Half-life (T 1/2)

    Time frame: 0 to 168 hours post dose

  5. Percent total recovery of radioactivity in blood, urine, and feces

    Time frame: 0 to 648 hours post dose

  6. Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration

    Time frame: 0 to 168 hours post dose

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Baseline to 27 days

Sponsors and collaborators

Lead sponsor

Global Blood Therapeutics

Industry

Registry information

Official study title

A Phase 1 Study to Investigate Absorption, Metabolism, and Excretion After Establishment of Steady State Via GBT440 Loading and Maintenance Dosing Followed by a Single Oral Dose Administration of [14C]-GBT440 in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 15, 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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