Clinical trial NCT03155503: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects
Official title: A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-911 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder, Major
Keywords: SUVN-911
Depression
single dose
multiple dose
alpha4 beta2 receptor
first in human
safety
pharmacokinetics
tolerability
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: subjects randomized to drug or placebo
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the safety, tolerability, and pharmacokinetic profile.

Detailed description: This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-911 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions.

The primary objectives are to evaluate the safety and tolerability of SUVN-911 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-911, if possible.

The secondary objectives are to evaluate the single and repeat dose plasma and urine pharmacokinetics of SUVN-911 following oral administration of single and multiple ascending doses in healthy male subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy male aged 18 to 45 years with a body mass index (BMI) between 18 and 30 kg/m2, (inclusive).

Exclusion Criteria:

* Standard exclusion criterion for Phase 1 clinical trial in healthy subjects:

  * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate.
  * History or presence of gastro intestinal (GI), hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.

Primary outcomes:
measure: ECG (Electrocardiogram)
timeFrame: Range of Day 1-17
measure: Vital signs
timeFrame: Range of Day 1-17
measure: C-SSRS (Columbia Suicidal Severity Rating Scale)
timeFrame: Range of Day 1-17
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Day 1 and Day 14
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1 and Day 14
measure: Time to reach maximum concentration (Tmax)
timeFrame: Day 1 and Day 14
measure: Terminal half-life (t½)
timeFrame: Day 1 and Day 14
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: QuintilesIMS Phase 1 Services, LLC
state: Kansas
Study officials:
affiliation: Quintiles, Inc.
name: Barbara Lomeli
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.