Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673593
• Other study ID #: DS102A-01
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2016
• Last updated: February 3, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: DS Biopharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DS102

• Placebo

Locations

Country	Name	City	State
Ireland	DS Biopharma Investigational Site	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
DS Biopharma

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No