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

NCT ID: NCT02821312

Last Updated: 2016-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-04-30

Brief Summary

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.

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).

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active in Group A1~A7

In each of Groups A1 to A7, 8 subjects will receive DA-8010.

Group Type: ACTIVE_COMPARATOR

DA-8010

Intervention Type: DRUG

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 in Group A1~A7

In each of Groups A1 to A7, 2 subjects will receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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 in Group B1~B4

In each of Groups B1 to B4, 8 subjects will receive DA-8010.

Group Type: ACTIVE_COMPARATOR

DA-8010

Intervention Type: DRUG

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 in Group B1~B4

In each of Groups B1 to B4, 2 subjects will receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jisu Song

Role: STUDY_DIRECTOR

Dong-A ST

Central Contacts

Sujin Cho

Role: CONTACT

csjin@donga.co.kr

8229208329

Other Identifiers

DA8010_OAB_I

Identifier Type: -

Identifier Source: org_study_id