Back to resultsA Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects (SUVN-911)
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SUVN-911
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring SUVN-911, Depression, single dose, multiple dose, alpha4 beta2 receptor, first in human, safety, pharmacokinetics, tolerability
Eligibility 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.
Sites / Locations
- QuintilesIMS Phase 1 Services, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single ascending dose
Multiple ascending dose
Arm Description
Single dose of SUVN-911 or placebo in healthy male subjects
Multiple doses of SUVN-911 or placebo in healthy male subjects
Outcomes
Primary Outcome Measures
ECG (Electrocardiogram)
electrocardiogram outcomes
Vital signs
blood pressure determination
C-SSRS (Columbia Suicidal Severity Rating Scale)
Columbia Suicidal Severity Rating in multiple doses
Secondary Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Plasma concentration
Maximum observed concentration (Cmax)
Maximum concentration observed
Time to reach maximum concentration (Tmax)
Determination of maximum time taken to reach the maximum concentration
Terminal half-life (t½)
Elimination rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03155503
Brief Title
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
March 7, 2018 (Actual)
Study Completion Date
March 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suven Life Sciences Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
SUVN-911, Depression, single dose, multiple dose, alpha4 beta2 receptor, first in human, safety, pharmacokinetics, tolerability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
subjects randomized to drug or placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single ascending dose
Arm Type
Active Comparator
Arm Description
Single dose of SUVN-911 or placebo in healthy male subjects
Arm Title
Multiple ascending dose
Arm Type
Active Comparator
Arm Description
Multiple doses of SUVN-911 or placebo in healthy male subjects
Intervention Type
Drug
Intervention Name(s)
SUVN-911
Intervention Description
Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
ECG (Electrocardiogram)
Description
electrocardiogram outcomes
Time Frame
Range of Day 1-17
Title
Vital signs
Description
blood pressure determination
Time Frame
Range of Day 1-17
Title
C-SSRS (Columbia Suicidal Severity Rating Scale)
Description
Columbia Suicidal Severity Rating in multiple doses
Time Frame
Range of Day 1-17
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Description
Plasma concentration
Time Frame
Day 1 and Day 14
Title
Maximum observed concentration (Cmax)
Description
Maximum concentration observed
Time Frame
Day 1 and Day 14
Title
Time to reach maximum concentration (Tmax)
Description
Determination of maximum time taken to reach the maximum concentration
Time Frame
Day 1 and Day 14
Title
Terminal half-life (t½)
Description
Elimination rate
Time Frame
Day 1 and Day 14
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Lomeli
Organizational Affiliation
Quintiles, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
QuintilesIMS Phase 1 Services, LLC
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35963959
Citation
Nirogi R, Benade V, Goyal VK, Pandey SK, Mohammed AR, Shinde A, Dogiparti D, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of Ropanicant (SUVN-911), a Novel Alpha4 Beta2 Nicotinic Acetylcholine Receptor (alpha4beta2 nAChR) Antagonist, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2022 Sep;42(9):747-762. doi: 10.1007/s40261-022-01189-9. Epub 2022 Aug 13.
Results Reference
derived
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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects
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