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

Dong-A ST

Status and phase: Unknown; Phase 1

Conditions: Overactive Bladder

Treatments: Drug: Placebo; Drug: DA-8010

Study type: Interventional

Funder types: Industry

Identifiers

NCT02821312

DA8010_OAB_I

Details and patient eligibility

About

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.

Full 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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 4 patient groups, including a placebo group

Active in Group A1~A7

Active Comparator group

Description:

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

Treatment:

Drug: DA-8010

Placebo in Group A1~A7

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Active in Group B1~B4

Active Comparator group

Description:

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

Treatment:

Drug: DA-8010

Placebo in Group B1~B4

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo