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

Anemia, Sickle Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497924
• Other study ID #: GBT440-002
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2015
• Last updated: April 10, 2017
• Start date: June 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Global Blood Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell

Intervention

Drug:
• GBT440
GBT440 capsules followed by single dose of [C14] GBT440 oral suspension

Locations

Country	Name	City	State
United States	Covance Early Clinical Services	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Global Blood Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the whole blood and plasma concentration versus time curve (AUC)		0 to 648 hours post dose
Primary	Peak whole blood and plasma concentration (Cmax)		0 to 168 hours post dose
Primary	Time to peak whole blood and plasma concentration (Tmax)		0 to 168 hours post dose
Primary	Half-life (T 1/2)		0 to 168 hours post dose
Primary	Percent total recovery of radioactivity in blood, urine, and feces		0 to 648 hours post dose
Primary	Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration		0 to 168 hours post dose
Secondary	Number of participants with adverse events		Baseline to 27 days