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

Completed · Phase 1

Conditions studied: Cognitive Disorder

In brief

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

Key facts

Study ID: NCT03031574
Run by: Suven Life Sciences Limited
People needed: 28
Starts: 2017-01-23
Expected to finish: 2017-09-07
Last updated by the study team: 2017-09-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

PRA Health Sciences — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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