A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Cognitive Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 4/21/2016 |
Start Date: | September 2014 |
End Date: | August 2015 |
A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-G3031 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
SUVN-G3031 in healthy male subjects following single or multiple ascending doses.
SUVN-G3031 in healthy male subjects following single or multiple ascending doses.
This is a single and multiple ascending dose study to assess the safety, tolerability and
pharmacokinetics of SUVN-G3031 administered orally once a day to healthy male subjects. The
study will be conducted under double-blind conditions.
The primary objective is to evaluate the safety and tolerability of SUVN-G3031 following
oral administration of single or multiple ascending doses and estimate the maximum tolerated
dose of SUVN-G3031, if possible.
The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics
following oral administration of single and multiple ascending doses of SUVN-G3031 in
healthy male subjects.
pharmacokinetics of SUVN-G3031 administered orally once a day to healthy male subjects. The
study will be conducted under double-blind conditions.
The primary objective is to evaluate the safety and tolerability of SUVN-G3031 following
oral administration of single or multiple ascending doses and estimate the maximum tolerated
dose of SUVN-G3031, if possible.
The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics
following oral administration of single and multiple ascending doses of SUVN-G3031 in
healthy male subjects.
Inclusion Criteria:
• Healthy male aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive).
Exclusion Criteria:
- Standard exclusion criterion for Phase 1 clinical trial in healthy subjects.
- History of any clinically significant disease or disorder which, in the opinion of
the Investigator, may either put the volunteer at risk because of participation in
the study, or influence the results or the volunteer's ability to participate
- History or presence of GI, hepatic, or renal disease or any other condition known to
interfere with absorption, distribution, metabolism, or excretion of drugs as judged
by Investigator.
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