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

Major Depressive Disorder Clinical Trial

— SUVN-911  

Official title:

A Phase I, Single-Center, Single Dose Study to Evaluate the Effect of Food, Gender, and Age on Safety and Pharmacokinetic Profiles of SUVN-911 Tablets Orally Administered in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551288
• Other study ID #: CTP1S2911A4B2
• Status: Completed
• Phase: Phase 1
• Start date: May 22, 2018
• Est. completion date: July 16, 2018

Study information

• Verified date: August 2018
• Source: Suven Life Sciences Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 16, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• SUVN-911
Tablet

Locations

Country	Name	City	State
United States	IQVIA Phase One Services, LLC	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Suven Life Sciences Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under concentration (AUC)	Plasma concentration versus time	24 hours
Secondary	Vital signs	blood pressure determination	24 hours