A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03155503

Acronym

SUVN-911

Enrollment

Registered

2017-05-16

Start date

2017-05-22

Completion date

2018-03-14

Last updated

2018-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Keywords

SUVN-911, Depression, single dose, multiple dose, alpha4 beta2 receptor, first in human, safety, pharmacokinetics, tolerability

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.

Interventions

DRUGSUVN-911

Oral Tablet

DRUGPlacebo

Oral Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double blind

Intervention model description

subjects randomized to drug or placebo

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
ECG (Electrocardiogram)	Range of Day 1-17	electrocardiogram outcomes
Vital signs	Range of Day 1-17	blood pressure determination
C-SSRS (Columbia Suicidal Severity Rating Scale)	Range of Day 1-17	Columbia Suicidal Severity Rating in multiple doses

Secondary

Measure	Time frame	Description
Area under the plasma concentration versus time curve (AUC)	Day 1 and Day 14	Plasma concentration
Terminal half-life (t½)	Day 1 and Day 14	Elimination rate
Maximum observed concentration (Cmax)	Day 1 and Day 14	Maximum concentration observed
Time to reach maximum concentration (Tmax)	Day 1 and Day 14	Determination of maximum time taken to reach the maximum concentration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026