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Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02673593
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
DS Biopharma

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: DS102 Drug: Placebo Phase 1

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official 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
Study Start Date : July 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Taken orally as a single dose (Cohorts 1 - 4) Taken orally as a multiple daily dose for 28 days (Cohorts 5 - 7)
 Drug: Placebo
Experimental: DS102 100mg Single Dose
Taken orally once by Cohort 1
 Drug: DS102
Experimental: DS102 500mg Single Dose
Single Dose taken orally on three separate occasions by Cohort 2 (second and third dose assessing food effect)
 Drug: DS102
Experimental: DS102 1000mg Single Dose
Taken orally once by Cohort 3
 Drug: DS102
Experimental: DS102 2000mg Single Dose
Taken orally once by Cohort 4
 Drug: DS102
Experimental: DS102 500mg Multiple Dose
Taken orally once a day for 28 days by Cohort 5
 Drug: DS102
Experimental: DS102 1000mg Multiple Dose
Taken orally once a day for 28 days by Cohort 6
 Drug: DS102
Experimental: DS102 2000mg Multiple Dose
Taken orally once a day for 28 days by Cohort 7
 Drug: DS102


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673593


Locations
Ireland
DS Biopharma Investigational Site
Belfast, Ireland
Sponsors and Collaborators
DS Biopharma
More Information
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Responsible Party: DS Biopharma
ClinicalTrials.gov Identifier: NCT02673593     History of Changes
Other Study ID Numbers: DS102A-01
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: January 2016

Keywords provided by DS Biopharma:
Safety
Pharmacokinetics
Food Effect