Clinical trial NCT03551288: Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: SUVN-911
Depression
alpha4 beta2 receptor
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2018-06-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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

Eligibility 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.

Primary outcomes:
measure: Area under concentration (AUC)
timeFrame: 24 hours
Secondary outcomes:
measure: Vital signs
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: IQVIA Phase One Services, LLC
state: Kansas
Study officials:
affiliation: IQVIA Phase One Services, LLC
name: Barbara Lomeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.