A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the safety, tolerability, and pharmacokinetic profile.

Key facts

Study ID

NCT03155503

Run by

Suven Life Sciences Limited

People needed

64

Starts

2017-05-22

Expected to finish

2018-03-14

Last updated by the study team

2018-05-29

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy male aged 18 to 45 years with a body mass index (BMI) between 18 and 30 kg/m2, (inclusive).

You may not qualify if…

• 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 gastro intestinal (GI), hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.

Where it is running

• QuintilesIMS Phase 1 Services, LLC — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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