A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects

This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: DA-8010; Drug: Placebo

Detailed Description

This study will be a randomised, double-blind, placebo-controlled, dose-escalation, single and multiple oral dose study conducted in 2 parts.

In Part A, each subject will participate in 1 treatment period only and reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 3 (48 hours postdose), except for Group A4, where each subject will participate in 2 treatment periods separated by a minimum of 13 days to evaluate the effect of food.

In Part B, each subject will participate in 1 treatment period only and reside at the CRU from Day -1 (1 day before dosing) until the morning of Day 9 (48 hours after the final dose on Day 7).

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI between 18.0 and 32.0 kg/m2
• Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

• Subjects who do not agree to use a method of acceptable contraception
• Female subjects of child-bearing potential who do not agree to use a highly effective method of birth control
• Consume more than 28 or 21 units of alcohol per week if male or female, respective
• Subjects who have used nicotine-containing products (including cigarettes), within 3 months prior to the first dose administration
• Subjects who have used, or intend to use the product like non-prescribed systemic or topical medication, herbal remedy, vitamin/mineral supplement, within 7 days of the first dose administration
• Systolic blood pressure < 90 mmHg or > 140 mmHg
• Diastolic blood pressure < 50 mmHg or > 90 mmHg
• Pulse rate < 45 bpm or > 100 bpm
• Positive urine drugs of abuse screen at screening or first admission
• Positive alcohol breath test at screening or first admission
• Positive cotinine test at screening or first admission
• Abnormality in the 12-lead ECG at screening, admission or predose on Day 1
• Subjects who are pregnant, breastfeeding, or lactating
• Subjects who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of any investigational drug in the past 3 months prior to the first dose administration
• Subjects who have a significant history of drug allergy, as determined by the Investigator
• Aspartate aminotransferase and/or Alanine aminotransferase ≥ 1.5 × upper limit of normal (ULN) or total bilirubin > ULN at screening or admission
• Subjects who are carriers of HBsAg or hepatitis C antibody, have serum hepatitis or positive result for the test for HIV antibodies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active in Group A1~A7; In each of Groups A1 to A7, 8 subjects will receive DA-8010.	Drug: DA-8010; Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 8 subject for DA-8010. Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 8 subject for DA-8010.
Placebo Comparator: Placebo in Group A1~A7; In each of Groups A1 to A7, 2 subjects will receive placebo.	Drug: Placebo; Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 2 subject for DA-8010. Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 2 subject for DA-8010.
Active Comparator: Active in Group B1~B4; In each of Groups B1 to B4, 8 subjects will receive DA-8010.	Drug: DA-8010; Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 8 subject for DA-8010. Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 8 subject for DA-8010.
Placebo Comparator: Placebo in Group B1~B4; In each of Groups B1 to B4, 2 subjects will receive placebo.	Drug: Placebo; Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 2 subject for DA-8010. Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 2 subject for DA-8010.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).	during 10 days in Part A
Safety and Tolerability	Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).	during 16 days in Part B

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve (AUC)	48 hours
Maximum observed plasma concentration (Cmax)	48 hours
Time of the maximum observed plasma concentration (tmax)	48 hours

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Study Director: Jisu Song, Dong-A ST

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: June 19, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; DA-8010
• Other Study ID Numbers: DA8010_OAB_I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO