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

NCT03551288 | Completed Phase 1 FDA Drug

• 1 other identifier: CTP1S2911A4B2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder

Keywords

SUVN-911; Depression; alpha4 beta2 receptor

Outcome Measures

Primary Outcomes (1)

• Area under concentration (AUC)

  Plasma concentration versus time

  24 hours

Secondary Outcomes (1)

• Vital signs

  24 hours

Study Arms (3)

Food Effect Cohort

EXPERIMENTAL

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

Gender Effect Cohort

EXPERIMENTAL

Eight healthy female subjects 18 to 45 years of age, inclusive, will be administered a single dose of SUVN-911.

Drug: SUVN-911

Age Effect Cohort

EXPERIMENTAL

Eight healthy male subjects ≥ 65 years of age will be administered a single oral dose of SUVN-911.

Drug: SUVN-911

Interventions

SUVN-911 DRUG

Tablet

Age Effect Cohort; Food Effect Cohort; Gender Effect Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suven Life Sciences Limited: lead

Study Sites (1)

IQVIA Phase One Services, LLC

Kansas City, Kansas, 66211, United States

Location

Related Publications (1)

• Nirogi R, Benade V, Goyal VK, Pandey SK, Mohammed AR, Shinde A, Dogiparti D, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of Ropanicant (SUVN-911), a Novel Alpha4 Beta2 Nicotinic Acetylcholine Receptor (alpha4beta2 nAChR) Antagonist, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2022 Sep;42(9):747-762. doi: 10.1007/s40261-022-01189-9. Epub 2022 Aug 13.

  PMID: 35963959 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Barbara Lomeli, MD

  IQVIA Phase One Services, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 11, 2018
• Study Start: May 22, 2018
• Primary Completion: July 10, 2018
• Study Completion: July 16, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)