A phase 1, open-label study to assess the absorption, metabolism, and excretion, including the mass balance, of a single oral dose of [14C]-etrumadenant in healthy male subjects

A phase 1, open-label study to assess the absorption, metabolism, and excretion, including the mass balance, of a single oral dose of [14C]-etrumadenant in healthy male subjects - AME study with etrumadenant

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51599

Enrollment

Registered

2022-04-19

Start date

2022-05-06

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, tumors Cancer tumors

Interventions

The volunteer will be given 150 mg of 14C-labeled etrumadenant with an oral syringe (without needle) on Day 1. This amount contains 3.7 MBq radioactivity (this corresponds to a radiation exposure of

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Sex at birth : male. 2. Age : 18 to 55 years, inclusive, at screening. 3. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive, at screening. 4. Body weight : >=50 kg, inclusive, at screening. 5. Status : healthy subjects. Further criteria apply, see protocol.

Exclusion criteria

Exclusion criteria: 1. Employee of PRA or the Sponsor. 2. History of relevant drug and/or food allergies. 3. Using tobacco products within 2 months prior to drug administration. 4. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) over the past 2 years. 5. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or (first) admission to the clinical research center. Further criteria apply, see protocol.

Design outcomes

Primary

Measure	Time frame
- To determine the time course of excretion of total radioactivity in urine and feces after a single oral dose of 150 mg [14C] etrumadenant containing 3.7 MBq of radioactivity. - To determine the recovery of total radioactivity (mass balance) as a percentage of the administered dose after a single oral dose of 150 mg [14C]-etrumadenant containing 3.7 MBq of radioactivity. - To determine the percentage of total radioactivity present as [14C] etrumadenant in urine and feces at selected time points after a single oral dose of 150 mg [14C] etrumadenant containing 3.7 MBq of radioactivity. - To assess the safety and tolerability of a single oral dose of 150 mg [14C] etrumadenant containing 3.7 MBq of radioactivity.	—

Measure

Time frame

- To determine the time course of excretion of total radioactivity in urine and feces after a single oral dose of 150 mg [14C] etrumadenant containing 3.7 MBq of radioactivity. - To determine the recovery of total radioactivity (mass balance) as a percentage of the administered dose after a single oral dose of 150 mg [14C]-etrumadenant containing 3.7 MBq of radioactivity. - To determine the percentage of total radioactivity present as [14C] etrumadenant in urine and feces at selected time points after a single oral dose of 150 mg [14C] etrumadenant containing 3.7 MBq of radioactivity. - To assess the safety and tolerability of a single oral dose of 150 mg [14C] etrumadenant containing 3.7 MBq of radioactivity.

—

Secondary

Measure	Time frame
- To assess the pharmacokinetics (PK) of total radioactivity etrumadenant and selected metabolites in plasma after a single oral dose of 150 mg [14C]-etrumadenant containing 3.7 MBq of radioactivity. - To determine the percentage of total radioactivity associated with erythrocytes in whole blood over time after a single oral dose of 150 mg [14C]-etrumadenant containing 3.7 MBq of radioactivity.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)