Clinical trial NCT02497924: A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia, Sickle Cell
Lead sponsor: Global Blood Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-07-15
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the whole blood and plasma concentration versus time curve (AUC)
timeFrame: 0 to 648 hours post dose
measure: Peak whole blood and plasma concentration (Cmax)
timeFrame: 0 to 168 hours post dose
measure: Time to peak whole blood and plasma concentration (Tmax)
timeFrame: 0 to 168 hours post dose
measure: Half-life (T 1/2)
timeFrame: 0 to 168 hours post dose
measure: Percent total recovery of radioactivity in blood, urine, and feces
timeFrame: 0 to 648 hours post dose
measure: Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration
timeFrame: 0 to 168 hours post dose
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Baseline to 27 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Early Clinical Services
state: Wisconsin
Study officials:
affiliation: Global Blood Therapeutics
name: Carla Washington, PhD
role: STUDY_DIRECTOR
References: