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

April 10, 2017 updated by: Global Blood Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Covance Early Clinical Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GBT440
GBT440 / [C14] GBT440
Drug: GBT440
GBT440 capsules followed by single dose of [C14] GBT440 oral suspension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Baseline to 27 days
Baseline to 27 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global Blood Therapeutics

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBT440-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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