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Trial record 6 of 31 for:    CTPS1

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

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ClinicalTrials.gov Identifier: NCT03551288
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SUVN-911 Phase 1

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be enrolled in 1 of 3 cohorts; Cohort 1 (Food Effect Cohort), Cohort 2 (Gender Effect Cohort), and Cohort 3 (Age Effect Cohort). Subjects in Cohort 1 will receive a single oral dose of SUVN-911 on Day 1 under fasted or fed conditions and again on Day 8 under fasted or fed conditions (crossover design). Subjects in Cohort 2 and Cohort 3 will receive a single oral dose of SUVN-911 on Day 1.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 22, 2018
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Food Effect Cohort
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.
Drug: SUVN-911
Tablet

Experimental: Gender Effect Cohort
Eight healthy female subjects 18 to 45 years of age, inclusive, will be administered a single dose of SUVN-911.
Drug: SUVN-911
Tablet

Experimental: Age Effect Cohort
Eight healthy male subjects ≥ 65 years of age will be administered a single oral dose of SUVN-911.
Drug: SUVN-911
Tablet




Primary Outcome Measures :
  1. Area under concentration (AUC) [ Time Frame: 24 hours ]
    Plasma concentration versus time


Secondary Outcome Measures :
  1. Vital signs [ Time Frame: 24 hours ]
    blood pressure determination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551288


Locations
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United States, Kansas
IQVIA Phase One Services, LLC
Kansas City, Kansas, United States, 66211
Sponsors and Collaborators
Suven Life Sciences Limited
Investigators
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Principal Investigator: Barbara Lomeli, MD IQVIA Phase One Services, LLC

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Responsible Party: Suven Life Sciences Limited
ClinicalTrials.gov Identifier: NCT03551288     History of Changes
Other Study ID Numbers: CTP1S2911A4B2
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suven Life Sciences Limited:
SUVN-911
Depression
alpha4 beta2 receptor
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders