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

Depressive Disorder, Major Clinical Trial

— SUVN-911  

Official title:

A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-911 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155503
• Other study ID #: CTP1S1911A4B2
• Status: Completed
• Phase: Phase 1
• Start date: May 22, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: May 2018
• Source: Suven Life Sciences Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 14, 2018
• Est. primary completion date: March 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• SUVN-911
Oral Tablet
• Placebo
Oral Tablet

Locations

Country	Name	City	State
United States	QuintilesIMS Phase 1 Services, LLC	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Suven Life Sciences Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG (Electrocardiogram)	electrocardiogram outcomes	Range of Day 1-17
Primary	Vital signs	blood pressure determination	Range of Day 1-17
Primary	C-SSRS (Columbia Suicidal Severity Rating Scale)	Columbia Suicidal Severity Rating in multiple doses	Range of Day 1-17
Secondary	Area under the plasma concentration versus time curve (AUC)	Plasma concentration	Day 1 and Day 14
Secondary	Maximum observed concentration (Cmax)	Maximum concentration observed	Day 1 and Day 14
Secondary	Time to reach maximum concentration (Tmax)	Determination of maximum time taken to reach the maximum concentration	Day 1 and Day 14
Secondary	Terminal half-life (t½)	Elimination rate	Day 1 and Day 14