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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02575482
Other study ID # CTP140105HT4
Secondary ID
Status Completed
Phase Phase 1
First received October 5, 2015
Last updated June 3, 2016
Start date July 2015
Est. completion date June 2016

Study information

Verified date June 2016
Source Suven Life Sciences Limited
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date June 2016
Est. primary completion date February 2016
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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SUVN-D4010

Placebo


Locations

Country Name City State
United States PRA Health Sciences Lenexa 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 Range of Day 1-17 Yes
Primary Physical exams Range of Day 1-17 Yes
Primary Vitals signs Range of Day 1-17 Yes
Primary CSSRS (suicidality) Columbia Suicidal Severity Rating Scale Range of Day 1-17 Yes
Primary Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects Incidence of Treatment-Emergent Adverse Events, Laboratory parameters Range of Day 1-17 Yes
Secondary Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau) Day 1 No
Secondary Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf) Day 14 No
Secondary Maximum observed concentration (Cmax) and time of observation (tmax) Day 1 and Day 14 No
Secondary Oral clearance (CL/F) Day 1 and Day 14 No
Secondary Accumulation index following multiple dosing of SUVN-D4010 (AI) Day 14 No
Secondary Elimination half life (t½) Day 1 and Day 14 No
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