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

Phase 1

• Conditions: Overactive Bladder
• Interventions: Drug: Placebo; Drug: DA-8010

• Registration Number: NCT02821312
• Lead Sponsor: Dong-A ST Co., Ltd.

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).

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-19
• Study First Submitted QC: 2016-06-29
• Last Update Submitted: 2016-06-29
• Study First Posted: 2016-07-01
• Last Update Posted: 2016-07-01
• Primary Completion: 2017-01
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo in Group A1~A7	Placebo	In each of Groups A1 to A7, 2 subjects will receive placebo.
Active in Group B1~B4	DA-8010	In each of Groups B1 to B4, 8 subjects will receive DA-8010.
Placebo in Group B1~B4	Placebo	In each of Groups B1 to B4, 2 subjects will receive placebo.
Active in Group A1~A7	DA-8010	In each of Groups A1 to A7, 8 subjects will receive DA-8010.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	during 16 days in Part B	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

Name	Time	Method
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