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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02821312
• Other study ID #: DA8010_OAB_I
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 19, 2016
• Last updated: June 29, 2016
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: June 2016
• Source: Dong-A ST Co., Ltd.
• Contact: Sujin Cho
• Phone: 8229208329
• Email: csjin[@]donga.co.kr
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	during 10 days in Part A	Yes
Primary	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).	during 16 days in Part B	Yes
Secondary	Area under the plasma concentration-time curve (AUC)		48 hours	No
Secondary	Maximum observed plasma concentration (Cmax)		48 hours	No
Secondary	Time of the maximum observed plasma concentration (tmax)		48 hours	No