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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects

Primary Purpose

Cognitive Disorders

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SUVN-G3031

Placebo

About this trial

This is an interventional treatment trial for Cognitive Disorders focused on measuring SUVN-G3031, histamine 3 (H3) receptor inverse agonist, first in human, safety, pharmacokinetics, tolerability, single dose, repeat dose

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Quintiles

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Arm Label

Single ascending dose

Multiple ascending dose

Arm Description

Single dose of SUVN-G3031or placebo in healthy male subjects

Multiple doses of SUVN-G3031 or placebo in healthy male subjects

Outcomes

Primary Outcome Measures

Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects

Safety variables - Adverse events, vital signs, electrocardiograms, telemetry, physical examination, and clinical laboratory assessments.

Secondary Outcome Measures

Area under the SUVN-G3031 plasma concentration-time curve in a dosing interval (AUC0-tau)

Area under the SUVN-G3031 plasma concentration-time curve from zero to infinity (AUC0-inf)

Maximum observed concentration (Cmax) and time of observation (tmax)

Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination half life (t½)

Accumulation index following multiple dosing of SUVN-G3031 (AI)

Full Information

NCT ID

NCT02342041

First Posted

January 10, 2015

Last Updated

October 13, 2016

Sponsor

Suven Life Sciences Limited

1. Study Identification

Unique Protocol Identification Number

NCT02342041

Brief Title

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Suven Life Sciences Limited

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-G3031 in healthy male subjects following single or multiple ascending doses.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Disorders

Keywords

SUVN-G3031, histamine 3 (H3) receptor inverse agonist, first in human, safety, pharmacokinetics, tolerability, single dose, repeat dose

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single ascending dose

Arm Type

Placebo Comparator

Arm Description

Single dose of SUVN-G3031or placebo in healthy male subjects

Arm Title

Multiple ascending dose

Arm Type

Placebo Comparator

Arm Description

Multiple doses of SUVN-G3031 or placebo in healthy male subjects

Intervention Type

Drug

Intervention Name(s)

SUVN-G3031

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects

Description

Safety variables - Adverse events, vital signs, electrocardiograms, telemetry, physical examination, and clinical laboratory assessments.

Time Frame

Range of Day 1-19

Secondary Outcome Measure Information:

Title

Area under the SUVN-G3031 plasma concentration-time curve in a dosing interval (AUC0-tau)

Time Frame

Day 1

Title

Area under the SUVN-G3031 plasma concentration-time curve from zero to infinity (AUC0-inf)

Time Frame

Day 14

Title

Maximum observed concentration (Cmax) and time of observation (tmax)

Time Frame

Day 1 and Day 14

Title

Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination half life (t½)

Time Frame

Day 1 and Day 14

Title

Accumulation index following multiple dosing of SUVN-G3031 (AI)

Time Frame

Day 14

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Murtaugh Thomas, MD

Organizational Affiliation

Senior Medical Research Director

Official's Role

Principal Investigator

Facility Information:

Facility Name

Quintiles

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32399853

Citation

Nirogi R, Mudigonda K, Bhyrapuneni G, Muddana NR, Shinde A, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses. Clin Drug Investig. 2020 Jul;40(7):603-615. doi: 10.1007/s40261-020-00920-8.

Results Reference

derived

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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects

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