Overview

This trial is active, not recruiting.

Condition anemia, sickle cell
Treatment gbt440
Phase phase 1
Sponsor Global Blood Therapeutics
Start date June 2015
End date December 2015
Trial size 7 participants
Trial identifier NCT02497924, GBT440-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
GBT440 / [C14] GBT440
gbt440
GBT440 capsules followed by single dose of [C14] GBT440 oral suspension

Primary Outcomes

Measure
Area under the whole blood and plasma concentration versus time curve (AUC)
time frame: 0 to 648 hours post dose
Peak whole blood and plasma concentration (Cmax)
time frame: 0 to 168 hours post dose
Time to peak whole blood and plasma concentration (Tmax)
time frame: 0 to 168 hours post dose
Half-life (T 1/2)
time frame: 0 to 168 hours post dose
Percent total recovery of radioactivity in blood, urine, and feces
time frame: 0 to 648 hours post dose
Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration
time frame: 0 to 168 hours post dose

Secondary Outcomes

Measure
Number of participants with adverse events
time frame: Baseline to 27 days

Eligibility Criteria

Male participants from 18 years up to 55 years old.

Inclusion Criteria: 1. Healthy; non-smoking male; 18 to 55 years old, inclusive 2. Weighs at least 50 kg and not more than 110 kg 3. Agrees to use contraception 4. Willing and able to give written informed consent Exclusion Criteria: 1. Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder 2. History of stomach or intestinal surgery that would potentially alter drug absorption 3. History of hypersensitivity or allergy to drugs, foods, or other substances 4. History or presence of abnormal electrocardiogram 5. Exposure to significant radiation or participated in more than 1 other radiolabeled study drug trial within 12 months of Screening 6. 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

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Global Blood Therapeutics.