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Status unknownNCT02821312Updated Jul 1, 2016

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

A Phase 1 interventional study of DA-8010 and Placebo in Overactive Bladder, sponsored by Dong-A ST Co., Ltd.. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-01.

Sponsored by Dong-A ST Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Overactive Bladder
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's planned enrollment of 110 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Active comparator
    Active in Group A1~A7

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

    Drug: DA-8010

  • Placebo comparator
    Placebo in Group A1~A7

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

    Drug: Placebo

  • Active comparator
    Active in Group B1~B4

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

    Drug: DA-8010

  • Placebo comparator
    Placebo in Group B1~B4

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

    Drug: Placebo

Interventions

  • DrugDA-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.

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: during 10 days in Part A

  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).

    Time frame: during 16 days in Part B

Secondary outcomes

  1. Area under the plasma concentration-time curve (AUC)

    Time frame: 48 hours

  2. Maximum observed plasma concentration (Cmax)

    Time frame: 48 hours

  3. Time of the maximum observed plasma concentration (tmax)

    Time frame: 48 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02821312
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Jul 1, 2016
Start date
Jun 2016
Primary completion
Jan 2017 (estimated)
Completion
Apr 2017 (estimated)
Last update
Jul 1, 2016

Study contacts

Sujin Cho
Contact
csjin@donga.co.kr
8229208329
Jisu Song
study director · Dong-A ST

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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