NCT02342041

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.

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 Sep 2014

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

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 14, 2016

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

January 10, 2015

Last Update Submit

October 13, 2016

Conditions

Cognitive Disorders

Keywords

SUVN-G3031histamine 3 (H3) receptor inverse agonistfirst in humansafetypharmacokineticstolerabilitysingle doserepeat dose

Outcome Measures

Primary Outcomes (1)

  • 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.

    Range of Day 1-19

Secondary Outcomes (5)

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

    Day 1

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

    Day 14

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

    Day 1 and Day 14

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

    Day 1 and Day 14

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

    Day 14

Study Arms (2)

Single ascending dose

PLACEBO COMPARATOR

Single dose of SUVN-G3031or placebo in healthy male subjects

Drug: SUVN-G3031Drug: Placebo

Multiple ascending dose

PLACEBO COMPARATOR

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

Drug: SUVN-G3031Drug: Placebo

Interventions

SUVN-G3031DRUG
Multiple ascending doseSingle ascending dose
PlaceboDRUG
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 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 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)

Quintiles

Overland Park, Kansas, 66211, United States

Location

Related Publications (1)

  • 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.

    PMID: 32399853DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

samelisant

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Murtaugh Thomas, MD

    Senior Medical Research Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2015

First Posted

January 19, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

October 14, 2016

Record last verified: 2015-09

Locations

US(1)