Taha El-Shahat
Madison, Wisconsin, 53704, United States
NCT Number: NCT06745271
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.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Madison, Wisconsin, 53704, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a. Males must agree to use contraception.
Exclusion criteria
Oral Capsule
Intravenous Solution
Time frame: Up to Day 42
Time frame: Up to Day 42
Time frame: Up to Day 42
Time frame: Up to Day 42
Time frame: Up to Day 42
Time frame: Up to Day 42
Time frame: Up to Day 42
Time frame: Up to Day 42
Time frame: Up to Day 7
Time frame: Up to Day 7
Time frame: Up to Day 21
Time frame: Up to Day 42
Time frame: Up to Day 21
Time frame: Up to Day 42
Time frame: Up to Day 21
Time frame: Up to Day 42
Time frame: Up to Day 21
Time frame: Up to Day 42
Time frame: Up to Day 21
Time frame: Up to Day 42
Time frame: Up to Day 42
Time frame: Up to Day 42
Time frame: Up to Day 21
Time frame: Up to Day 21
Time frame: Up to Day 21
Time frame: Up to Day 21
Time frame: Up to Day 21
Quantification of major metabolites of [14C]-tebapivat in plasma.
Time frame: Up to Day 42
Quantification of major metabolites of [14C]-tebapivat in excreta.
Time frame: Up to Day 21
Identification of the chemical structures of major metabolites of [14C]-tebapivat in plasma.
Time frame: Up to Day 42
Identification of the chemical structures of major metabolites of [14C]-tebapivat in excreta.
Time frame: Up to Day 28
Time frame: Baseline up to Day 28
Time frame: Baseline up to Day 28
Time frame: Baseline up to Day 28
Agios Pharmaceuticals, Inc.
Industry
A Phase I, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion and to Assess the Absolute Bioavailability Following a Single Oral Dose of [14C]-Tebapivat and Concomitant Single Intravenous Microdose of [13C2,15N3]-Tebapivat to Healthy Male Participants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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