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

Primary Purpose

Overactive Bladder

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

DA-8010

Placebo

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Active in Group A1~A7

Placebo in Group A1~A7

Active in Group B1~B4

Placebo in Group B1~B4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

Area under the plasma concentration-time curve (AUC)

Maximum observed plasma concentration (Cmax)

Time of the maximum observed plasma concentration (tmax)

Full Information

NCT ID

NCT02821312

First Posted

June 19, 2016

Last Updated

June 29, 2016

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02821312

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active in Group A1~A7

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo in Group A1~A7

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Active in Group B1~B4

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo in Group B1~B4

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

DA-8010

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety and Tolerability

Description

Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).

Time Frame

during 10 days in Part A

Title

Safety and Tolerability

Description

Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).

Time Frame

during 16 days in Part B

Secondary Outcome Measure Information:

Title

Area under the plasma concentration-time curve (AUC)

Time Frame

48 hours

Title

Maximum observed plasma concentration (Cmax)

Time Frame

48 hours

Title

Time of the maximum observed plasma concentration (tmax)

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sujin Cho

Phone

8229208329

csjin@donga.co.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jisu Song

Organizational Affiliation

Dong-A ST

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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