Autoimmune diseases and COVID-19 pneumonia
Conditions
Interventions
Period 1:
Day 1: once 100 milligrams (mg) 14C-enpatoran (including 30 kilobecquerel
14C-enpatoran) as an oral solution
Period 2:
Day 1: once 100 mg enpatoran as 4 oral tablets of 25 mg each + 30 kil
Sponsors
Merck Healthcare KGaA
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Period 1: To determine the rates and routes of excretion and mass balance of enpatoran following administration of a single oral dose of 100 mg enpatoran spiked with a microtracer (~30 kBq) of [14C]enpatoran in healthy male participants. To characterize the PK profile of total radioactivity in plasma and whole blood following administration of a single oral dose of 100 mg enpatoran spiked with a microtracer (~30 kBq) of [14C]enpatoran in healthy male participants. To characterize the PK profile of enpatoran in plasma and urine following administration of a single oral dose of 100 mg enpatoran spiked with a microtracer (~30 kBq) of [14C] enpatoran in healthy male participants. Period 2: To determine the absolute bioavailability (F) and PK of a single oral dose of 100 mg enpatoran followed by a single intravenous administration of a [14C]enpatoran microdose (~30 kBq) in healthy male participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Period 1: To evaluate the safety and tolerability of enpatoran administered as a single oral dose of 100 mg enpatoran spiked with a microtracer (~30 kBq) of [14C]enpatoran in healthy male participants. Period 2: To evaluate the safety and tolerability of a single oral dose of 100 mg enpatoran followed by a single intravenous administration of a [14C]enpatoran microdose (~30 kBq) in healthy male participants. | — |
Countries
Netherlands
Outcome results
None listed