Trials / Completed
CompletedNCT01485965
A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington Disease
A Phase 1b, Open-label, Parallel-group Study in Subjects With Huntington Disease to Assess the Safety, Tolerability, and Fed/Fasted Pharmacokinetics of Repeated Oral Doses of SEN0014196
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Siena Biotech S.p.A. · Industry
- Sex
- All
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to assess the effect of food upon the pharmacokinetics (PK) of SEN0014196 in subjects with Huntington disease (HD).
Detailed description
In addition to the pharmacokinetic endpoints, the study will assess the safety and tolerability of 100 mg once daily (qd) doses of SEN0014196 over 14 days in subjects with HD and explore potential biomarkers for use in subsequent Phase 2/3 studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SEN0014196 | 100 mg, immediate release tablets, once daily administration |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2012-11-01
- Completion
- 2012-12-01
- First posted
- 2011-12-06
- Last updated
- 2013-03-20
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01485965. Inclusion in this directory is not an endorsement.