A study investigating the effect of several doses of itraconazole on how the body processes RO7269162, a new compound in clinical development for the treatment of Alzheimer’s disease

Phase 1

• Conditions: Healthy volunteer; Not Applicable

• Registration Number: ISRCTN84512041
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-17
• Last Update Posted: 27 May 2024
• Study Completion: 2024-07-23

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 18

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified