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

• ClinicalTrials.gov Identifier: NCT02497924
• Recruitment Status: Completed
• First Posted: July 15, 2015
• Last Update Posted: April 12, 2017
• Sponsor: Global Blood Therapeutics
• Information provided by (Responsible Party): Global Blood Therapeutics

Tracking Information

• First Submitted Date: July 13, 2015
• First Posted Date: July 15, 2015
• Last Update Posted Date: April 12, 2017
• Actual Study Start Date: June 2015
• Actual Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 13, 2015)

• 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 ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: July 13, 2015): Number of participants with adverse events [ Time Frame: Baseline to 27 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Anemia, Sickle Cell

Intervention

Drug: GBT440

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

Study Arms

Experimental: GBT440

GBT440 / [C14] GBT440

Intervention: Drug: GBT440

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2015): 7
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2016
• Actual Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02497924
• Other Study ID Numbers: GBT440-002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Global Blood Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Global Blood Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Carla Washington, PhD; Global Blood Therapeutics

• PRS Account: Global Blood Therapeutics
• Verification Date: September 2015