Tebapivat for Healthy Subjects

Overseen By Agios Medical Affairs

Age: 18 - 65

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Agios Pharmaceuticals, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to determine the routes, rates of elimination, mass balance of total radioactivity and metabolite profiles following a single oral dose of \[14C\]-tebapivat. To characterize the PK of tebapivat and \[13C2,15N3\]-tebapivat and determine the absolute bioavailability following single oral dose of \[14C\]-tebapivat relative to single intravenous microdose of \[13C2,15N3\]-tebapivat to healthy male participants.

Eligibility Criteria

This trial is for healthy individuals who can participate in a study to understand how the body absorbs, breaks down, and eliminates a drug called Tebapivat. The details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am a man aged 18-55 and agree to use contraception.

Able to comprehend and willing to sign the informed consent form and abide by study restrictions

I have at least one bowel movement daily.

Exclusion Criteria

Use of tobacco- or nicotine-containing products within 3 months prior to check-in

I have not received or donated blood recently.

Participants deemed unsuitable by the investigator or designee

Treatment Details

Interventions

• [13C2,15N3]-tebapivat (Other)
• [14C]-tebapivat (Other)

Trial Overview The study is testing how Tebapivat behaves in the body after a single oral dose by tracking its breakdown products and elimination. It also aims to compare the availability of Tebapivat when taken orally versus through an intravenous microdose.

Participant Groups

Group I: [14C]-tebapivat and [13C2,15N3]-tebapivat Experimental Treatment 2 Interventions

Participants will receive a single oral dose of 10 milligrams (mg) \[14C\]-tebapivat containing 200 microcurie \[μCi\] of radiocarbon in a capsule followed by a single intravenous (IV) microdose of 0.1 mg \[13C2,15N3\]-tebapivat on Day 1.

Who Is Running the Clinical Trial?

Agios Pharmaceuticals, Inc.

Lead Sponsor

Trials

55

Recruited

4,200+