- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02342041
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects
A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-G3031 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-G3031 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-G3031 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-G3031, 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-G3031 in healthy male subjects.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66211
- Quintiles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Single ascending dose
Single dose of SUVN-G3031or placebo in healthy male subjects
|
|
Placebo Comparator: Multiple ascending dose
Multiple doses of SUVN-G3031 or placebo in healthy male subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects
Time Frame: Range of Day 1-19
|
Safety variables - Adverse events, vital signs, electrocardiograms, telemetry, physical examination, and clinical laboratory assessments.
|
Range of Day 1-19
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed concentration (Cmax) and time of observation (tmax)
Time Frame: Day 1 and Day 14
|
Day 1 and Day 14
|
Area under the SUVN-G3031 plasma concentration-time curve in a dosing interval (AUC0-tau)
Time Frame: Day 1
|
Day 1
|
Area under the SUVN-G3031 plasma concentration-time curve from zero to infinity (AUC0-inf)
Time Frame: Day 14
|
Day 14
|
Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination half life (t½)
Time Frame: Day 1 and Day 14
|
Day 1 and Day 14
|
Accumulation index following multiple dosing of SUVN-G3031 (AI)
Time Frame: Day 14
|
Day 14
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Murtaugh Thomas, MD, Senior Medical Research Director
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP13031H3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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