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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cognitive Disorder

Intervention / Treatment
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* Drug: SUVN-D4010


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Food Effect<br>SUVN-D4010 tablets single dose | Drug: SUVN-D4010<br>* Tablets<br>|
| Active Comparator: Gender Effect<br>SUVN-D4010 tablets single dose | Drug: SUVN-D4010<br>* Tablets<br>|
| Active Comparator: Age Effect<br>SUVN-D4010 tablets single dose | Drug: SUVN-D4010<br>* Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under concentration (AUC) |  | 72 hours | 
| Maximum observed concentration (Cmax) |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serotonin 4 (5-HT4) receptor, Phase 1