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Completed

NCT Number: NCT03031574

A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects

The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Lenexa, Kansas, 66219, United States

About this study

The main objective of the study is to evaluate the safety and tolerability of orally administered SUVN-D4010 under single-dose conditions in healthy adult male and female subjects and healthy elderly male subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects, aged 18 to 45 years, inclusive; healthy female subjects, aged 18 to 45 years, inclusive; healthy elderly male subjects, aged ≥65 years.
  • Have a body mass index (BMI) between 18.0 and 30.0kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg.

Exclusion criteria

  • History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of the study drug.
  • Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
  • Plasma or blood product donation within 1 month of the (first) administration of the study drug and any blood donation/blood loss more than 500 mL within the 2 months prior to the (first) administration of the study drug.
  • As judged by the Investigator that the subject should not participate in the study if he/she is considered unlikely to comply with study procedures, restrictions, and requirements.

Treatment and study plan

SUVN-D4010

Drug

Tablets

Primary outcomes

  1. Area under concentration (AUC)

    Time frame: 72 hours

  2. Maximum observed concentration (Cmax)

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Suven Life Sciences Limited

Industry

Registry information

Official study title

A Phase 1, Single-Center, Single-Dose, 2-Way Crossover, Randomized Food-Effect and Non-Randomized Gender- and Age- Effect Pharmacokinetic Study of SUVN-D4010 Orally Administered in Healthy Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2017
Registry last updated
Sep 25, 2017

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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