NCT03031574

Brief Summary

The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

January 23, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

January 23, 2017

Last Update Submit

September 21, 2017

Conditions

Cognitive Disorder

Keywords

Serotonin 4 (5-HT4) receptorPhase 1

Outcome Measures

Primary Outcomes (2)

  • Area under concentration (AUC)

    72 hours

  • Maximum observed concentration (Cmax)

    Day 1

Study Arms (3)

Food Effect

ACTIVE COMPARATOR

SUVN-D4010 tablets single dose

Drug: SUVN-D4010

Gender Effect

ACTIVE COMPARATOR

SUVN-D4010 tablets single dose

Drug: SUVN-D4010

Age Effect

ACTIVE COMPARATOR

SUVN-D4010 tablets single dose

Drug: SUVN-D4010

Interventions

SUVN-D4010DRUG

Tablets

Age EffectFood EffectGender Effect

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male subjects, aged 18 to 45 years, inclusive; healthy female subjects, aged 18 to 45 years, inclusive; healthy elderly male subjects, aged ≥65 years.
  • Have a body mass index (BMI) between 18.0 and 30.0kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg.

You may not qualify if:

  • History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of the study drug.
  • Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
  • Plasma or blood product donation within 1 month of the (first) administration of the study drug and any blood donation/blood loss more than 500 mL within the 2 months prior to the (first) administration of the study drug.
  • As judged by the Investigator that the subject should not participate in the study if he/she is considered unlikely to comply with study procedures, restrictions, and requirements.

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, MD, PhD

    PRA Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 25, 2017

Study Start

January 23, 2017

Primary Completion

August 29, 2017

Study Completion

September 7, 2017

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)