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

Suven Life Sciences

Status and phase: Completed; Phase 1

Conditions: Depressive Disorder, Major

Treatments: Drug: Placebo; Drug: SUVN-911

Study type: Interventional

Funder types: Industry

Identifiers

NCT03155503

CTP1S1911A4B2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

64 participants in 2 patient groups

Single ascending dose

Active Comparator group

Description:

Single dose of SUVN-911 or placebo in healthy male subjects

Treatment:

Drug: Placebo

Drug: SUVN-911

Multiple ascending dose

Active Comparator group

Description:

Multiple doses of SUVN-911 or placebo in healthy male subjects

Treatment:

Drug: Placebo

Drug: SUVN-911