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

NCT02821312 | Unknown Phase 1

• 1 other identifier: DA8010_OAB_I
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• 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

Study Arms (4)

Active in Group A1~A7

ACTIVE COMPARATOR

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

Drug: DA-8010

Placebo in Group A1~A7

PLACEBO COMPARATOR

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

Drug: Placebo

Active in Group B1~B4

ACTIVE COMPARATOR

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

Drug: DA-8010

Placebo in Group B1~B4

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DA-8010 DRUG

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.

Active in Group A1~A7; Active in Group B1~B4

Placebo DRUG

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.

Placebo in Group A1~A7; Placebo in Group B1~B4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

DA-8010

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jisu Song

  Dong-A ST

  STUDY DIRECTOR

Central Study Contacts

Sujin Cho

CONTACT

8229208329; csjin@donga.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: July 1, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 1, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share