Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
NCT ID: NCT02673593
Last Updated: 2016-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2015-07-31
2015-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Placebo
Taken orally as a single dose (Cohorts 1 - 4) Taken orally as a multiple daily dose for 28 days (Cohorts 5 - 7)
Placebo
DS102 100mg Single Dose
Taken orally once by Cohort 1
DS102
DS102 500mg Single Dose
Single Dose taken orally on three separate occasions by Cohort 2 (second and third dose assessing food effect)
DS102
DS102 1000mg Single Dose
Taken orally once by Cohort 3
DS102
DS102 2000mg Single Dose
Taken orally once by Cohort 4
DS102
DS102 500mg Multiple Dose
Taken orally once a day for 28 days by Cohort 5
DS102
DS102 1000mg Multiple Dose
Taken orally once a day for 28 days by Cohort 6
DS102
DS102 2000mg Multiple Dose
Taken orally once a day for 28 days by Cohort 7
DS102
Interventions
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DS102
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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DS Biopharma
INDUSTRY
Responsible Party
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Locations
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DS Biopharma Investigational Site
Belfast, , Ireland
Countries
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Other Identifiers
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DS102A-01
Identifier Type: -
Identifier Source: org_study_id
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