Tebapivat for Healthy Subjects

Overseen By Agios Medical Affairs

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Agios Pharmaceuticals, Inc.

Must not be taking: St. John's wort

Disqualifiers: Metabolic, Hepatic, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

8 Participants Needed

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of 10 mg [14C]-tebapivat and a single intravenous microdose of 0.1 mg [13C2,15N3]-tebapivat on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quantification and identification of metabolites

6 weeks

Multiple visits (in-person)

Treatment Details

Interventions

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

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+