Phase I, Open-Label, 2-Period, Single-Sequence Study to Evaluate the Mass Balance and Absorption, Disposition, Metabolism and Excretion of [14C] enpatoran, and the Absolute Bioavailability of Enpatoran in Healthy Male Participants

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

Age
1. Are 18 to 55 years of age at the time of signing the informed consent.

Type of Participant and Disease Characteristics
2. Are overtly healthy as determined by medical evaluation, including medical
history, physical examination, laboratory tests, and cardiac monitoring (blood
pressure, heart rate and 12 lead ECG). Rescreening might be permitted as
described in Section 5.4 of the protocol.

Weight
3. Have a body weight within 50 to 110 kg and BMI within the range >= 18.0 and <=
30.0 kg/m2 (inclusive).

Sex and Contraception/Barrier Requirements
4. Are Male
The investigator confirms that each participant agrees to use an appropriate
contraception and barriers, if applicable. The contraception, barrier, and
pregnancy testing requirements are below.
Contraceptive use will be consistent with local regulations on contraception
methods for those participating in clinical studies.
Male participants
• Agree to the following during the study intervention period and for at least
3 months after the last dose of study intervention:
• Refrain from donating sperm
PLUS, either:
• Abstain from any activity that allows for exposure to ejaculate.
OR
• Use a male condom:
• When having sexual intercourse with a WOCBP, who is not currently pregnant,
and instruct her to use a highly effective contraceptive method
with a failure rate of <1% per year, as described in Appendix 3, since a condom
may break or leak.
• When engaging in any activity that allows for exposure to ejaculate.
• Note: Also use male condom when having sexual intercourse with a pregnant
woman.

Informed Consent
5. Capable of giving signed informed consent, as indicated in Appendix 2 of the
protocol which includes compliance with the requirements and restrictions
listed in the ICF and this protocol.

Exclusion Criteria

Medical Conditions
1. History or presence of clinically relevant respiratory, gastrointestinal,
renal, hepatic, hematological, lymphatic, neurological, cardiovascular,
psychiatric, musculoskeletal, genitourinary, immunological, dermatological,
connective tissue diseases or disorders.
2. Prior history of cholecystectomy or splenectomy, and any clinically relevant
surgery within 6 months prior to Screening.
3. Any surgical or medical condition which might significantly alter the ADME
of drugs, or which may jeopardize the participant in case of participation in
the study.
4. History of any malignancy.
5. History or presence of epilepsy, neurological disorders with seizure
propensity or undiagnosed loss of consciousness, severe head trauma within 6
months or severe depression within 12 months prior to Screening), or
neuropsychiatric conditions.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 10/31/2022

Phase I, Open-Label, 2-Period, Single-Sequence Study to Evaluate the Mass Balance and Absorption, Disposition, Metabolism and Excretion of [14C] enpatoran, and the Absolute Bioavailability of Enpatoran in Healthy Male Participants

Recruitment & Eligibility

Study & Design

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