A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects

A Phase 1, Single-Center, Single-Dose, 2-Way Crossover, Randomized Food-Effect and Non-Randomized Gender- and Age- Effect Pharmacokinetic Study of SUVN-D4010 Orally Administered in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03031574

Enrollment

Registered

2017-01-25

Start date

2017-01-23

Completion date

2017-09-07

Last updated

2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Disorder

Keywords

Serotonin 4 (5-HT4) receptor, Phase 1

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.

Detailed description

The main objective of the study is to evaluate the safety and tolerability of orally administered SUVN-D4010 under single-dose conditions in healthy adult male and female subjects and healthy elderly male subjects.

Interventions

DRUGSUVN-D4010

Tablets

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Area under concentration (AUC)	72 hours
Maximum observed concentration (Cmax)	Day 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026