A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects

Suven Life Sciences

Status and phase: Completed; Phase 1

Conditions: Cognitive Disorders

Treatments: Drug: SUVN-G3031

Study type: Interventional

Funder types: Industry

Identifiers

NCT02881294

CTP1S23031H3

Details and patient eligibility

About

The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive) for food and gender effect
• Healthy male aged 60 to 70 years with a BMI between 18 and 32 kg/m2, (inclusive) for age effect

Exclusion criteria

• History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug.
• Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

Food Effect

Active Comparator group

Description:

SUVN-G3031 tablets single dose

Treatment:

Drug: SUVN-G3031

Gender Effect

Active Comparator group

Description:

SUVN-G3031 tablets single dose

Treatment:

Drug: SUVN-G3031

Age Effect

Active Comparator group

Description:

SUVN-G3031 tablets single dose

Treatment:

Drug: SUVN-G3031