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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02575482
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Suven Life Sciences Limited

Brief Summary:
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 in healthy male subjects following single or multiple ascending doses.

Condition or disease Intervention/treatment Phase
Cognitive Disorders Drug: SUVN-D4010 Drug: Placebo Phase 1

Detailed Description:

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-D4010 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-D4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-D4010,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-D4010 in healthy male subjects.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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-D4010 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
Study Start Date : July 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Single and Multiple ascending dose
Single dose of SUVN-D4010 in healthy male subjects
Drug: SUVN-D4010
Placebo Comparator: Placebo
Placebo in healthy male subjects
Drug: Placebo



Primary Outcome Measures :
  1. ECG [ Time Frame: Range of Day 1-17 ]
  2. Physical exams [ Time Frame: Range of Day 1-17 ]
  3. Vitals signs [ Time Frame: Range of Day 1-17 ]
  4. CSSRS (suicidality) [ Time Frame: Range of Day 1-17 ]
    Columbia Suicidal Severity Rating Scale

  5. Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects [ Time Frame: Range of Day 1-17 ]
    Incidence of Treatment-Emergent Adverse Events, Laboratory parameters


Secondary Outcome Measures :
  1. Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau) [ Time Frame: Day 1 ]
  2. Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf) [ Time Frame: Day 14 ]
  3. Maximum observed concentration (Cmax) and time of observation (tmax) [ Time Frame: Day 1 and Day 14 ]
  4. Oral clearance (CL/F) [ Time Frame: Day 1 and Day 14 ]
  5. Accumulation index following multiple dosing of SUVN-D4010 (AI) [ Time Frame: Day 14 ]
  6. Elimination half life (t½) [ Time Frame: Day 1 and Day 14 ]


Information from the National Library of Medicine

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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 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.

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): NCT02575482


Locations
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United States, Kansas
PRA Health Sciences
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Suven Life Sciences Limited
Investigators
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Principal Investigator: Daniel Dickerson Research Physician

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Responsible Party: Suven Life Sciences Limited
ClinicalTrials.gov Identifier: NCT02575482     History of Changes
Other Study ID Numbers: CTP140105HT4
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Keywords provided by Suven Life Sciences Limited:
SUVN-D4010
serotonin 4 (5-HT4) receptor
first in human
safety
pharmacokinetics
tolerability
single dose
repeat dose
Additional relevant MeSH terms:
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Cognition Disorders
Neurocognitive Disorders
Mental Disorders