A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects (SUVN-911)

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Placebo; Drug: SUVN-911

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66211
      • QuintilesIMS Phase 1 Services, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single ascending dose; Single dose of SUVN-911 or placebo in healthy male subjects	Drug: Placebo; Oral Tablet; Drug: SUVN-911; Oral Tablet
Active Comparator: Multiple ascending dose; Multiple doses of SUVN-911 or placebo in healthy male subjects	Drug: Placebo; Oral Tablet; Drug: SUVN-911; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC)	Plasma concentration	Day 1 and Day 14
Maximum observed concentration (Cmax)	Maximum concentration observed	Day 1 and Day 14
Time to reach maximum concentration (Tmax)	Determination of maximum time taken to reach the maximum concentration	Day 1 and Day 14
Terminal half-life (t½)	Elimination rate	Day 1 and Day 14

Collaborators and Investigators

• Sponsor: Suven Life Sciences Limited
• Investigators: Principal Investigator: Barbara Lomeli, Quintiles, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): March 7, 2018
• Study Completion (Actual): March 14, 2018

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 13, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 29, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Depression; tolerability; safety; pharmacokinetics; single dose; first in human; multiple dose; SUVN-911; alpha4 beta2 receptor
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: CTP1S1911A4B2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No