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

Completed

• Conditions: 10028302; spinal muscular atrophy

• Registration Number: NL-OMON42781
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 93

Inclusion Criteria

Healthy volunteers
18 - 45 years, inclusive
BMI 18 - 30 kilogram/meter2, inclusive
non smokers or less then 6 sigarettes per day

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of single ascending oral doses of<br /><br>RO7034067 in healthy male subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To investigate the single dose oral pharmacokinetics (PK) of RO7034067 (and<br /><br>its metabolite(s) if appropriate), in plasma and urine.<br /><br>* To investigate the pharmacodynamic (PD) effect of single ascending oral doses<br /><br>of RO7034067 on SMN2 mRNA splicing modification and SMN protein increase.<br /><br>* To explore the pharmacokinetic/pharmacodynamic (PK/PD) relationship of single<br /><br>ascending oral doses of RO7034067 on SMN2 mRNA splicing modification and SMN<br /><br>protein increase.<br /><br>* To assess the effect of food on the PK of a single oral dose of RO7034067.<br /><br>* To investigate the effect of multiple oral doses of itraconazole on the<br /><br>pharmacokinetics of a single oral dose of RO7034067 in healthy male subjects<br /><br>* To assess the safety and tolerability of a single oral dose of RO7034067 in<br /><br>combination with itraconazole in healthy male subjects</p><br>