NCT02673593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2015

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
Last Updated

February 4, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

January 21, 2016

Last Update Submit

February 3, 2016

Conditions

Healthy

Keywords

SafetyPharmacokineticsFood Effect

Outcome Measures

Primary Outcomes (18)

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

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

    14 days

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

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

    14 days

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

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

    14 days

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

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

    14 days

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

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

    14 days

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

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

    14 days

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

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

    14 days

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

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

    14 days

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

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

    42 days

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

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

    42 days

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

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

    42 days

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

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

    42 days

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

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

    42 days

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

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

    42 days

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

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

    42 days

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

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

    42 days

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

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

    42 days

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

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

    42 days

Study Arms (8)

Placebo

PLACEBO COMPARATOR

Taken orally as a single dose (Cohorts 1 - 4) Taken orally as a multiple daily dose for 28 days (Cohorts 5 - 7)

Drug: Placebo

DS102 100mg Single Dose

EXPERIMENTAL

Taken orally once by Cohort 1

Drug: DS102

DS102 500mg Single Dose

EXPERIMENTAL

Single Dose taken orally on three separate occasions by Cohort 2 (second and third dose assessing food effect)

Drug: DS102

DS102 1000mg Single Dose

EXPERIMENTAL

Taken orally once by Cohort 3

Drug: DS102

DS102 2000mg Single Dose

EXPERIMENTAL

Taken orally once by Cohort 4

Drug: DS102

DS102 500mg Multiple Dose

EXPERIMENTAL

Taken orally once a day for 28 days by Cohort 5

Drug: DS102

DS102 1000mg Multiple Dose

EXPERIMENTAL

Taken orally once a day for 28 days by Cohort 6

Drug: DS102

DS102 2000mg Multiple Dose

EXPERIMENTAL

Taken orally once a day for 28 days by Cohort 7

Drug: DS102

Interventions

DS102DRUG
DS102 1000mg Multiple DoseDS102 1000mg Single DoseDS102 100mg Single DoseDS102 2000mg Multiple DoseDS102 2000mg Single DoseDS102 500mg Multiple DoseDS102 500mg Single Dose
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DS Biopharma Investigational Site

Belfast, Ireland

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 4, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 4, 2016

Record last verified: 2016-01

Locations

IE(1)