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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects

Primary Purpose

Cognitive Disorders

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SUVN-D4010

Placebo

About this trial

This is an interventional treatment trial for Cognitive Disorders focused on measuring SUVN-D4010, serotonin 4 (5-HT4) receptor, 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

PRA Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Single and Multiple ascending dose

Placebo

Arm Description

Single dose of SUVN-D4010 in healthy male subjects

Placebo in healthy male subjects

Outcomes

Primary Outcome Measures

ECG

Physical exams

Vitals signs

CSSRS (suicidality)

Columbia Suicidal Severity Rating Scale

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

Incidence of Treatment-Emergent Adverse Events, Laboratory parameters

Secondary Outcome Measures

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

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

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

Oral clearance (CL/F)

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

Elimination half life (t½)

Full Information

NCT ID

NCT02575482

First Posted

October 5, 2015

Last Updated

June 3, 2016

Sponsor

Suven Life Sciences Limited

1. Study Identification

Unique Protocol Identification Number

NCT02575482

Brief Title

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 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-D4010 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

June 2016 (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-D4010 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-D4010 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-D4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-D4010,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-D4010 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-D4010, serotonin 4 (5-HT4) receptor, 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 and Multiple ascending dose

Arm Type

Experimental

Arm Description

Single dose of SUVN-D4010 in healthy male subjects

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo in healthy male subjects

Intervention Type

Drug

Intervention Name(s)

SUVN-D4010

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

ECG

Time Frame

Range of Day 1-17

Title

Physical exams

Time Frame

Range of Day 1-17

Title

Vitals signs

Time Frame

Range of Day 1-17

Title

CSSRS (suicidality)

Description

Columbia Suicidal Severity Rating Scale

Time Frame

Range of Day 1-17

Title

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

Description

Incidence of Treatment-Emergent Adverse Events, Laboratory parameters

Time Frame

Range of Day 1-17

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 1

Title

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

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)

Time Frame

Day 1 and Day 14

Title

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

Time Frame

Day 14

Title

Elimination half life (t½)

Time Frame

Day 1 and 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

Daniel Dickerson

Organizational Affiliation

Research Physician

Official's Role

Principal Investigator

Facility Information:

Facility Name

PRA Health Sciences

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33788154

Citation

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.

Results Reference

derived

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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects

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