Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects

Phase 1

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: SUVN-911

• Registration Number: NCT03551288
• Lead Sponsor: Suven Life Sciences Limited

Brief Summary

The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects

Detailed Description

This is a Phase I, single-center, open-label, single dose study to evaluate the effect of food, gender, and age on the safety and Pharmacokinetic profiles of single doses of SUVN-911, administered orally in healthy subjects.

The primary objective is to evaluate the effect of food, gender, and age on the pharmacokinetics of a single dose of SUVN-911 administered orally to healthy subjects.

The secondary objective is to evaluate the safety and tolerability of a single dose of SUVN-911 administered orally to healthy adult male, female, and elderly subjects

Study Timeline

• Study Start: 2018-05-22
• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-05-28
• Study First Posted: 2018-06-11
• Primary Completion: 2018-07-10
• Study Completion: 2018-07-16
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Healthy male subjects, 18 to 45 years of age (inclusive) for Cohort 1, healthy female subjects, 18 to 45 years of age (inclusive) for Cohort 2, and healthy male subjects ≥ 65 years of age (inclusive) for Cohort 3, at the time of signing the informed consent.

Subjects in Cohorts 1 and 2 must have a body weight of at least 50 kg and body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive). Elderly subjects in Cohort 3 must have a body weight of at least 50 kg and BMI within the range of 18 to 32 kg/m2 (inclusive)

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Exclusion Criteria

History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.

History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

Any clinically important illness, medical/surgical procedure, or trauma within 28 days of the first administration of the study treatment (Day 1).

Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.

Any positive result at Screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gender Effect Cohort	SUVN-911	Eight healthy female subjects 18 to 45 years of age, inclusive, will be administered a single dose of SUVN-911.
Food Effect Cohort	SUVN-911	Twelve healthy male subjects 18 to 45 years of age, inclusive, will be administered a single oral dose of SUVN-911 on Day 1 (Period 1) and Day 8 (Period 2) with and without food in a crossover manner.
Age Effect Cohort	SUVN-911	Eight healthy male subjects ≥ 65 years of age will be administered a single oral dose of SUVN-911.

Primary Outcome Measures

Name	Time	Method
Area under concentration (AUC)	24 hours	Plasma concentration versus time

Secondary Outcome Measures

Name	Time	Method
Vital signs	24 hours	blood pressure determination

Trial Locations

Locations (1)

IQVIA Phase One Services, LLC; 🇺🇸 Kansas City, Kansas, United States