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Trial record 7 of 31 for:    CTPS1

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

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ClinicalTrials.gov Identifier: NCT03155503
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: SUVN-911 Drug: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: subjects randomized to drug or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
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
Actual Study Start Date : May 22, 2017
Actual Primary Completion Date : March 7, 2018
Actual Study Completion Date : March 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Single ascending dose
Single dose of SUVN-911 or placebo in healthy male subjects
Drug: SUVN-911
Oral Tablet

Drug: Placebo
Oral Tablet

Active Comparator: Multiple ascending dose
Multiple doses of SUVN-911 or placebo in healthy male subjects
Drug: SUVN-911
Oral Tablet

Drug: Placebo
Oral Tablet




Primary Outcome Measures :
  1. ECG (Electrocardiogram) [ Time Frame: Range of Day 1-17 ]
    electrocardiogram outcomes

  2. Vital signs [ Time Frame: Range of Day 1-17 ]
    blood pressure determination

  3. C-SSRS (Columbia Suicidal Severity Rating Scale) [ Time Frame: Range of Day 1-17 ]
    Columbia Suicidal Severity Rating in multiple doses


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Day 1 and Day 14 ]
    Plasma concentration

  2. Maximum observed concentration (Cmax) [ Time Frame: Day 1 and Day 14 ]
    Maximum concentration observed

  3. Time to reach maximum concentration (Tmax) [ Time Frame: Day 1 and Day 14 ]
    Determination of maximum time taken to reach the maximum concentration

  4. Terminal half-life (t½) [ Time Frame: Day 1 and Day 14 ]
    Elimination rate



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155503


Locations
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United States, Kansas
QuintilesIMS Phase 1 Services, LLC
Kansas City, Kansas, United States, 66211
Sponsors and Collaborators
Suven Life Sciences Limited
Investigators
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Principal Investigator: Barbara Lomeli Quintiles, Inc.

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Responsible Party: Suven Life Sciences Limited
ClinicalTrials.gov Identifier: NCT03155503     History of Changes
Other Study ID Numbers: CTP1S1911A4B2
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suven Life Sciences Limited:
SUVN-911
Depression
single dose
multiple dose
alpha4 beta2 receptor
first in human
safety
pharmacokinetics
tolerability
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders