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

Phase 1

Completed

• Conditions: Cognitive Disorder
• Interventions: Drug: SUVN-D4010

• Registration Number: NCT03031574
• Lead Sponsor: Suven Life Sciences Limited

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.

Study Timeline

• Study Start: 2017-01-23
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Primary Completion: 2017-08-29
• Status Verified: 2017-09
• Study Completion: 2017-09-07
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food Effect	SUVN-D4010	SUVN-D4010 tablets single dose
Gender Effect	SUVN-D4010	SUVN-D4010 tablets single dose
Age Effect	SUVN-D4010	SUVN-D4010 tablets single dose

Primary Outcome Measures

Name	Time	Method
Area under concentration (AUC)	72 hours
Maximum observed concentration (Cmax)	Day 1

Trial Locations

Locations (1)

PRA Health Sciences; 🇺🇸 Lenexa, Kansas, United States