Clinical trial NCT02821312: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Overactive Bladder
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: during 10 days in Part A
measure: Safety and Tolerability
timeFrame: during 16 days in Part B
Secondary outcomes:
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 48 hours
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 48 hours
measure: Time of the maximum observed plasma concentration (tmax)
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Dong-A ST
name: Jisu Song
role: STUDY_DIRECTOR
References: