Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects

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

Tracking Information

• First Submitted Date: January 21, 2016
• First Posted Date: February 4, 2016
• Last Update Posted Date: February 4, 2016
• Study Start Date: July 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 3, 2016)

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
• 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

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.

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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Condition: Healthy

Intervention

• Drug: DS102
• Drug: Placebo

Study Arms

• 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)
  Intervention: Drug: Placebo
• Experimental: DS102 100mg Single Dose
  Taken orally once by Cohort 1
  Intervention: 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)
  Intervention: Drug: DS102
• Experimental: DS102 1000mg Single Dose
  Taken orally once by Cohort 3
  Intervention: Drug: DS102
• Experimental: DS102 2000mg Single Dose
  Taken orally once by Cohort 4
  Intervention: Drug: DS102
• Experimental: DS102 500mg Multiple Dose
  Taken orally once a day for 28 days by Cohort 5
  Intervention: Drug: DS102
• Experimental: DS102 1000mg Multiple Dose
  Taken orally once a day for 28 days by Cohort 6
  Intervention: Drug: DS102
• Experimental: DS102 2000mg Multiple Dose
  Taken orally once a day for 28 days by Cohort 7
  Intervention: Drug: DS102

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 3, 2016): 57
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ireland

Administrative Information

• NCT Number: NCT02673593
• Other Study ID Numbers: DS102A-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: DS Biopharma
• Original Responsible Party: Same as current
• Current Study Sponsor: DS Biopharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: DS Biopharma
• Verification Date: January 2016