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Completed

NCT Number: NCT02673593

Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects

The purpose of the study is to investigate the safety, pharmacokinetics and food effect of DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants.

DS102 capsules will be orally administered for up to 4 weeks, and will be compared against placebo.

The study will enrol approximately 56 adult subjects.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DS Biopharma Investigational Site

Belfast, Ireland

About this study

There will be 7 cohorts enrolled, each consisting of 8 subjects.

Cohorts 1 - 4 will be orally administered up to 2000mg single doses of DS102 on Day 1.

Cohorts 5 - 7 will be orally administered up to 2000mg multiple daily doses of DS102 for 28 days.

The primary objective is to assess the safety and plasma pharmacokinetics of single and multiple daily oral doses of DS102.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is male or female and is aged between 18 and 45 years inclusive.
  • Subject's body mass index (BMI) is between 18.0 and 30.0 kg/m2 inclusive.
  • Subject is a non-smoker, has been a non-smoker for 3 months prior to screening and has a negative urine cotinine test at screening.

Exclusion criteria

  • Subject has had a clinically significant illness in the 4 weeks before screening.
  • Use of prescribed medication in the 2 weeks before dosing or over-the-counter preparations (including vitamins and supplements) for 1 week before dosing
  • Subject has a significant history of drug/solvent abuse, or a positive drugs of abuse (DOA) test at screening or Day -1.
  • Subject with a history of alcohol abuse in the opinion of the Investigator, or who currently drinks in excess of 28 units per week (males) or 21 units per week (females), whereby a unit consists of 10ml or 8mg of pure alcohol, or who have a positive alcohol urine test at screening or Day -1.
  • Subject has participated in any other clinical study with an investigational drug/device within 3 months before the first day of administration of study treatment.
  • Subject has a positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.
  • Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
  • Subject has donated blood or blood products within 3 months before screening.
  • Subject has known hypersensitivity to any ingredients of the study treatment.

Treatment and study plan

DS102

Drug

Placebo

Drug

Primary outcomes

  1. Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a single dose

    Time frame: 14 days

    Phase I study - Overall safety of product in first in man study

  2. Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a single dose

    Time frame: 14 days

    Phase I study - Overall PK of product in first in man study

  3. Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a single dose

    Time frame: 14 days

    Phase I study - Overall PK of product in first in man study

  4. Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a single dose

    Time frame: 14 days

    Phase I study - Overall PK of product in first in man study

  5. Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a single dose

    Time frame: 14 days

    Phase I study - Overall PK of product in first in man study

  6. Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a single dose

    Time frame: 14 days

    Phase I study - Overall PK of product in first in man study

  7. Pharmacokinetics (Plasma concentrations assessed by Vz/F ) of DS102 administered as a single dose

    Time frame: 14 days

    Phase I study - Overall PK of product in first in man study

  8. Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a single dose

    Time frame: 14 days

    Phase I study - Overall PK of product in first in man study

  9. Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a multiple dose for 28 days

    Time frame: 42 days

    Phase I study - Overall safety of product in first in man study

  10. Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a multiple dose

    Time frame: 42 days

    Phase I study - Overall PK of product in first in man study

  11. Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a multiple dose

    Time frame: 42 days

    Phase I study - Overall PK of product in first in man study

  12. Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a multiple dose

    Time frame: 42 days

    Phase I study - Overall PK of product in first in man study

  13. Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a multiple dose

    Time frame: 42 days

    Phase I study - Overall PK of product in first in man study

  14. Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a multiple dose

    Time frame: 42 days

    Phase I study - Overall PK of product in first in man study

  15. Pharmacokinetics (Plasma concentrations assessed by Vz/F) of DS102 administered as a multiple dose

    Time frame: 42 days

    Phase I study - Overall PK of product in first in man study

  16. Pharmacokinetics (Plasma concentrations assessed by AUC 0-24) of DS102 administered as a multiple dose

    Time frame: 42 days

    Phase I study - Overall PK of product in first in man study

  17. Pharmacokinetics (Plasma concentrations assessed by Css) of DS102 administered as a multiple dose

    Time frame: 42 days

    Phase I study - Overall PK of product in first in man study

  18. Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a multiple dose

    Time frame: 42 days

    Phase I study - Overall PK of product in first in man study

Sponsors and collaborators

Lead sponsor

DS Biopharma

Industry

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Dose Phase I Study to Assess the Safety, Pharmacokinetics and Effect of Food on Orally Administered DS102 in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2016
Registry last updated
Feb 4, 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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