A Phase 1 Study to Assess the Mass Balance, Excretion, and Pharmacokinetics of [14C]-GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Healthy Participants

Completed

Conditions: sickle cell anemia
sickle cell disease
10038158

Registration Number: NL-OMON53865

Lead Sponsor: Global Blood Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

1. Sex: Male or female.
2. Age: 18 to 55 years, inclusive, at screening.
3. Body mass index (BMI): 18.0 to 27.0 kg/m2, inclusive, at screening.
4. Body weight: >=50 kg at screening.
5. Good physical and mental health on the basis of medical and surgical
history, physical examination, clinical laboratory (including clinical
chemistry, hematology, urinalysis, and coagulation), 12 lead electrocardiogram
(ECG), and vital signs, as judged by the Investigator.

Further criteria apply

Exclusion Criteria

1. Employee of ICON or the Sponsor.
2. History or presence of clinically significant allergic diseases (except for
untreated, asymptomatic, seasonal allergies at time of dosing), in the opinion
of the Investigator.
3. History or presence of conditions which, in the opinion of the Investigator,
are known to interfere with the ADME of drugs, such as previous surgery on the
gastrointestinal tract (including removal of parts of the stomach, bowel,
liver, gall bladder, or pancreas). Participants who have a history of
appendectomy are eligible for enrollment.
4. History of chronic constipation, or recent complaints of an irregular
defecation pattern (ie, less than once per day on average) in the opinion of
the Investigator.
5. History of surgery requiring general anesthesia (not including local
procedures) or major trauma within 12 weeks of screening, or a planned surgery
during participation in the study.

Further criteria apply

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To determine the whole blood and plasma concentrations of [14C]-GBT021601<br /><br>total radioactivity.<br /><br>- To assess the mass balance by determining [14C]-GBT021601 total radioactivity<br /><br>excreted in urine and feces.<br /><br>- To determine the PK of GBT021601 in whole blood, plasma, and urine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the safety and tolerability of GBT021601 administration in healthy<br /><br>participants.<br /><br>- To characterize and identify metabolites of [14C]-GBT021601 in whole blood,<br /><br>plasma, urine, and feces.</p><br>