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

NCT02497924 | Completed Phase 1

• 1 other identifier: GBT440-002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia, Sickle Cell

Outcome Measures

Primary Outcomes (6)

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

  0 to 648 hours post dose

• Peak whole blood and plasma concentration (Cmax)

  0 to 168 hours post dose

• Time to peak whole blood and plasma concentration (Tmax)

  0 to 168 hours post dose

• Half-life (T 1/2)

  0 to 168 hours post dose

• Percent total recovery of radioactivity in blood, urine, and feces

  0 to 648 hours post dose

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

  0 to 168 hours post dose

Secondary Outcomes (1)

• Number of participants with adverse events

  Baseline to 27 days

Study Arms (1)

GBT440

EXPERIMENTAL

GBT440 / \[C14\] GBT440

Drug: GBT440

Interventions

GBT440 DRUG

GBT440 capsules followed by single dose of \[C14\] GBT440 oral suspension

GBT440

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Global Blood Therapeutics: lead

Study Sites (1)

Covance Early Clinical Services

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

voxelotor

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, 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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 15, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 12, 2017

Record last verified: 2015-09

Locations

US (1)