NCT03155503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

May 11, 2017

Last Update Submit

May 25, 2018

Conditions

Depressive Disorder, Major

Keywords

SUVN-911Depressionsingle dosemultiple dosealpha4 beta2 receptorfirst in humansafetypharmacokineticstolerability

Outcome Measures

Primary Outcomes (3)

  • ECG (Electrocardiogram)

    electrocardiogram outcomes

    Range of Day 1-17

  • Vital signs

    blood pressure determination

    Range of Day 1-17

  • C-SSRS (Columbia Suicidal Severity Rating Scale)

    Columbia Suicidal Severity Rating in multiple doses

    Range of Day 1-17

Secondary Outcomes (4)

  • Area under the plasma concentration versus time curve (AUC)

    Day 1 and Day 14

  • Maximum observed concentration (Cmax)

    Day 1 and Day 14

  • Time to reach maximum concentration (Tmax)

    Day 1 and Day 14

  • Terminal half-life (t½)

    Day 1 and Day 14

Study Arms (2)

Single ascending dose

ACTIVE COMPARATOR

Single dose of SUVN-911 or placebo in healthy male subjects

Drug: SUVN-911Drug: Placebo

Multiple ascending dose

ACTIVE COMPARATOR

Multiple doses of SUVN-911 or placebo in healthy male subjects

Drug: SUVN-911Drug: Placebo

Interventions

SUVN-911DRUG

Oral Tablet

Multiple ascending doseSingle ascending dose
PlaceboDRUG

Oral Tablet

Multiple ascending doseSingle ascending dose

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male aged 18 to 45 years with a body mass index (BMI) between 18 and 30 kg/m2, (inclusive).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QuintilesIMS Phase 1 Services, LLC

Kansas City, Kansas, 66211, United States

Location

Related Publications (1)

  • 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.

    PMID: 35963959DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Barbara Lomeli

    Quintiles, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: subjects randomized to drug or placebo
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 16, 2017

Study Start

May 22, 2017

Primary Completion

March 7, 2018

Study Completion

March 14, 2018

Last Updated

May 29, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)