NCT02575482

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 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 Jul 2015

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

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

October 5, 2015

Last Update Submit

June 3, 2016

Conditions

Cognitive Disorders

Keywords

SUVN-D4010serotonin 4 (5-HT4) receptorfirst in humansafetypharmacokineticstolerabilitysingle doserepeat dose

Outcome Measures

Primary Outcomes (5)

  • ECG

    Range of Day 1-17

  • Physical exams

    Range of Day 1-17

  • Vitals signs

    Range of Day 1-17

  • CSSRS (suicidality)

    Columbia Suicidal Severity Rating Scale

    Range of Day 1-17

  • Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects

    Incidence of Treatment-Emergent Adverse Events, Laboratory parameters

    Range of Day 1-17

Secondary Outcomes (6)

  • Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau)

    Day 1

  • Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf)

    Day 14

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

    Day 1 and Day 14

  • Oral clearance (CL/F)

    Day 1 and Day 14

  • Accumulation index following multiple dosing of SUVN-D4010 (AI)

    Day 14

  • +1 more secondary outcomes

Study Arms (2)

Single and Multiple ascending dose

EXPERIMENTAL

Single dose of SUVN-D4010 in healthy male subjects

Drug: SUVN-D4010

Placebo

PLACEBO COMPARATOR

Placebo in healthy male subjects

Drug: Placebo

Interventions

SUVN-D4010DRUG
Single and Multiple ascending dose
PlaceboDRUG
Placebo

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)

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

  • Nirogi R, Bhyrapuneni G, Muddana NR, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT4 Partial Agonist, SUVN-D4010, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2021 May;41(5):469-482. doi: 10.1007/s40261-021-01027-4. Epub 2021 Mar 31.

    PMID: 33788154DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Daniel Dickerson

    Research Physician

    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

October 5, 2015

First Posted

October 14, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations

US(1)