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

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 - RO7034067 SAD/FE/DDI study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42781

Enrollment

Registered

2015-11-30

Start date

2015-12-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal muscular atrophy

Interventions

Part 1: cohort 1 (0.6 mg): 5 (3 active + 2 placebo) cohort 2 (2 mg): 4 (3 active + 1 placebo) cohort 3 (6 mg): 8 (6 active + 2 placebo) cohort 4 (20 mg): 8 (6 active + 2 placebo) cohort 5 (60 mg): 8 (

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of single ascending oral doses of RO7034067 in healthy male subjects.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)