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

Phase 1

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: SUVN-911; Drug: Placebo

• Registration Number: NCT03155503
• Lead Sponsor: Suven Life Sciences Limited

Brief Summary

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.

Detailed Description

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-911 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions.

The primary objectives are to evaluate the safety and tolerability of SUVN-911 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-911, if possible.

The secondary objectives are to evaluate the single and repeat dose plasma and urine pharmacokinetics of SUVN-911 following oral administration of single and multiple ascending doses in healthy male subjects.

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-13
• Study First Posted: 2017-05-16
• Study Start: 2017-05-22
• Primary Completion: 2018-03-07
• Study Completion: 2018-03-14
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Healthy male aged 18 to 45 years with a body mass index (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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple ascending dose	Placebo	Multiple doses of SUVN-911 or placebo in healthy male subjects
Single ascending dose	Placebo	Single dose of SUVN-911 or placebo in healthy male subjects
Single ascending dose	SUVN-911	Single dose of SUVN-911 or placebo in healthy male subjects
Multiple ascending dose	SUVN-911	Multiple doses of SUVN-911 or placebo in healthy male subjects

Primary Outcome Measures

Name	Time	Method
C-SSRS (Columbia Suicidal Severity Rating Scale)	Range of Day 1-17	Columbia Suicidal Severity Rating in multiple doses
Vital signs	Range of Day 1-17	blood pressure determination
ECG (Electrocardiogram)	Range of Day 1-17	electrocardiogram outcomes

Secondary Outcome Measures

Name	Time	Method
Time to reach maximum concentration (Tmax)	Day 1 and Day 14	Determination of maximum time taken to reach the maximum concentration
Area under the plasma concentration versus time curve (AUC)	Day 1 and Day 14	Plasma concentration
Maximum observed concentration (Cmax)	Day 1 and Day 14	Maximum concentration observed
Terminal half-life (t½)	Day 1 and Day 14	Elimination rate

Trial Locations

Locations (1)

QuintilesIMS Phase 1 Services, LLC; 🇺🇸 Kansas City, Kansas, United States