Healthy volunteer Not Applicable
Conditions
Interventions
Participants will receive a single dose of RO7269162, orally on Day 1 of Period 1. After an interval of at least 7 days, participants will receive itraconazole, orally, once daily, from Day -3 to Day
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Body mass index (BMI) of 18 to 30 kilograms per metre squared (kg/m2) inclusive (at screening) 2. Participants who are overtly healthy determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), or vital signs
Exclusion criteria
Exclusion criteria: 1. History or presence of any clinically significant cardiovascular, bronchopulmonary, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, psychiatric, genitourinary, metabolic disorders, allergic diseases, cancer, or cirrhosis 2. History or evidence of any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs 3. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract 4. History of malignancy in the past 5 years 5. Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection, or other Infection 6. Participation in an investigational drug study involving any therapeutic monoclonal antibody 7. Positive test for drugs of abuse or alcohol 8. Positive result on human immunodeficiency virus (HIV) 1 and HIV2, hepatitis C virus (HCV) or hepatitis B virus (HBV) 9. Participants who have donated over 500 milliliters (mL) of blood or blood products or had significant blood loss within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maximum observed plasma concentration (Cmax) of RO7269162 determined using blood samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 7 of Period 1 and Day 1 up to Day 14 of Period 2 2. Time to maximum plasma concentration (Tmax) of RO7269162 determined using blood samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 7 of Period 1 and Day 1 up to Day 14 of Period 2 3. Area under the plasma concentration-time curve from time zero up to the last measurable concentration (AUClast) of RO7269162 determined using blood samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 7 of Period 1 and Day 1 up to Day 14 of Period 2 4 Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of RO7269162 determined using blood samples collected at pre-dose and multiple time-points post-dose from Day 1 up to Day 7 of Period 1 and Day 1 up to Day 14 of Period 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of participants with adverse events (AEs) and severity of AEs determined according data captured on the electronic case report forms (eCRF) from Screening to Follow-up (up to approximately 9 weeks) 2. Plasma Concentration of itraconazole determined using blood samples collected at pre-dose and multiple time-points post-dose from Day -3 to Day 14 of Period 2 | — |
Countries
Netherlands
Contacts
Public ContactClinical Trials
Outcome results
None listed