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NCT Number: NCT02342041

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-G3031 in healthy male subjects following single or multiple ascending doses.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quintiles

Overland Park, Kansas, 66211, United States

About this study

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-G3031 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions.

The primary objective is to evaluate the safety and tolerability of SUVN-G3031 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-G3031, if possible.

The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of SUVN-G3031 in healthy male subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male aged 18 to 45 years with a 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 GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.

Treatment and study plan

SUVN-G3031

Drug

Placebo

Drug

Primary outcomes

  1. Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects

    Time frame: Range of Day 1-19

    Safety variables - Adverse events, vital signs, electrocardiograms, telemetry, physical examination, and clinical laboratory assessments.

Secondary outcomes

  1. Area under the SUVN-G3031 plasma concentration-time curve in a dosing interval (AUC0-tau)

    Time frame: Day 1

  2. Area under the SUVN-G3031 plasma concentration-time curve from zero to infinity (AUC0-inf)

    Time frame: Day 14

  3. Maximum observed concentration (Cmax) and time of observation (tmax)

    Time frame: Day 1 and Day 14

  4. Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination half life (t½)

    Time frame: Day 1 and Day 14

  5. Accumulation index following multiple dosing of SUVN-G3031 (AI)

    Time frame: Day 14

Sponsors and collaborators

Lead sponsor

Suven Life Sciences Limited

Industry

Registry information

Official study title

A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-G3031 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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