- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633723
Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
April 13, 2021 updated by: Dong-A ST Co., Ltd.
A Phase I, Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Trial With Open-labelled Food Effect Study of Single Dose to Investigate the Safety, Tolerability and Pharmacokinetics of DA-6886 After Oral Administration in Healthy Male Subjects
DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Songpa-gu
-
Seoul, Songpa-gu, Korea, Republic of, 138-736
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 20 ~ 45 years old
- 27kg/m2 ≥ BMI ≥ 20kg/m2
- Healthy Male
- Informed consent
Exclusion Criteria:
- Clinically significant medical history
- smokers
- Clinically significant hypersensitivity of Drugs
- Clinically significant cutaneous disorder
- QTcB > 450msec
- have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: DA-6886
|
single dose study : DA-6886 1mg,2.5mg,5mg,10mg,20mg dosage (Dose-escalation) multiple dose study : DA-6886 2.5mg,5mg,10mg or 5mg,10mg,20mg dosage (Dose-escalation) |
PLACEBO_COMPARATOR: DA-6886 placebo
|
DA-6886 placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of safety
Time Frame: up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)
|
|
up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics and Pharmacodynamics
Time Frame: up to 48 hours after last dosing of DA-6886
|
Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin
|
up to 48 hours after last dosing of DA-6886
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (ACTUAL)
April 1, 2014
Study Completion (ACTUAL)
April 1, 2014
Study Registration Dates
First Submitted
July 2, 2012
First Submitted That Met QC Criteria
July 3, 2012
First Posted (ESTIMATE)
July 4, 2012
Study Record Updates
Last Update Posted (ACTUAL)
April 15, 2021
Last Update Submitted That Met QC Criteria
April 13, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA6886_IBS_I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
-
ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
-
ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
-
Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
-
Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
-
University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
-
University of ViennaCompleted
-
Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
-
Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
-
Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
-
Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
Clinical Trials on DA-6886
-
Georgetown UniversityNational Cancer Institute (NCI); National Human Genome Research Institute (NHGRI)CompletedBreast Cancer | Ovarian CancerUnited States
-
Dong-A ST Co., Ltd.Completed
-
Dong-A ST Co., Ltd.Not yet recruiting
-
Dong-A ST Co., Ltd.RecruitingHepatitis BKorea, Republic of
-
Dong-A ST Co., Ltd.Completed
-
Dong-A ST Co., Ltd.CompletedHealthyKorea, Republic of
-
Myung-gui ChoiDong-A Pharmaceutical Co., Ltd.CompletedHealthy VolunteersKorea, Republic of
-
NeuroBo Pharmaceuticals Inc.Dong-A ST Co., Ltd.Completed
-
Dong-A ST Co., Ltd.Completed
-
Dong-A ST Co., Ltd.Not yet recruitingFunctional DyspepsiaKorea, Republic of