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NCT Number: NCT02575482

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 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

PRA Health Sciences

Lenexa, Kansas, 66219, United States

About this study

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-D4010 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-D4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-D4010,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-D4010 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-D4010

Drug

Placebo

Drug

Primary outcomes

  1. ECG

    Time frame: Range of Day 1-17

  2. Physical exams

    Time frame: Range of Day 1-17

  3. Vitals signs

    Time frame: Range of Day 1-17

  4. CSSRS (suicidality)

    Time frame: Range of Day 1-17

    Columbia Suicidal Severity Rating Scale

  5. Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects

    Time frame: Range of Day 1-17

    Incidence of Treatment-Emergent Adverse Events, Laboratory parameters

Secondary outcomes

  1. Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau)

    Time frame: Day 1

  2. Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf)

    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)

    Time frame: Day 1 and Day 14

  5. Accumulation index following multiple dosing of SUVN-D4010 (AI)

    Time frame: Day 14

  6. Elimination half life (t½)

    Time frame: Day 1 and 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-D4010 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2015
Registry last updated
Jun 6, 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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