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A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7034067 (RG7916) Given by Mouth in Healthy Volunteers
- Muscle And Peripheral Nerve Disease
- Spinal Muscular Atrophy (SMA)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
City
- Groningen
Trial Identifier:
NCT02633709 2015-004605-16 BP29840
Trial Summary
The objective of this study is to assess the safety and tolerability of Risdiplam (RO7034067) in healthy people. The study will assess what the body does to Risdiplam (RO7034067) and what Risdiplam (RO7034067) does to the body. Risdiplam (RO7034067) will be given by mouth in gradually increasing doses. The data from this study will help to define the dose to further explore Risdiplam (RO7034067) in patients with Spinal Muscular Atrophy.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT02633709,BP29840,2015-004605-16
Trial Identifier
Itraconazole, Placebo, Risdiplam
Treatments
Spinal Muscular Atrophy
Condition
Official Title
A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single-Ascending-Dose(SAD), Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food and the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of RO7034067), and Pharmacodynamics of RO7034067 Following Oral Administration in Healthy Subjects
Eligibility Criteria
Male
Gender
≥ 18 Years & ≤ 45 Years
Age
Accepts Healthy Volunteers
Healthy Volunteers
Inclusion Criteria
- Healthy men, aged 18 to 45 years of age, inclusive
- Body Mass Index (BMI) of 18 to 30 kilograms/meter square, inclusive
Exclusion Criteria
- History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
- History of malignancy in the past 5 years
- A history of clinically significant hypersensitivity (e.g. drugs, excipients) or allergic reactions
- Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first study drug administration
- History or presence of clinically significant electrocardiogram (ECG) abnormalities or cardiovascular disease
- Clinically significant abnormalities in laboratory test results
- Confirmed resting pulse rate (PR) greater than 100 or less than 40 bpm
- Confirmed systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
- Positive result on HIV1 and HIV2, hepatitis C (HCV) or hepatitis B (HBV)
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmological, dermatological, hematological or allergic disease, metabolic disorder, hypofertility, cancer or cirrhosis
- History or evidence of (neuro)muscular disorders
- Hypersensitivity to itraconazole, to any of the other ingredients, or to any other triazole antifungal
- Any other known contraindications to itraconazole
For the latest version of this information please go to www.forpatients.roche.com