Functional ConstipationPhase 1/2NCT02538367
Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation
A Phase 1/2 study testing YH12852 IR 0.05mg, YH12852 IR 0.1mg and YH12852 IR 0.3mg in people with Functional Constipation, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose, parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- YH12852 IR 0.05mg, YH12852 IR 0.1mg and YH12852 IR 0.3mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Sep 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be willing and able to provide written informed consent.
- BMI within the range 18 to 25 kg/m2.
Who cannot join
- History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.
- Clinically significant lab/ECG abnormalities in the opinion of the investigator.
- WOCBP who are unwilling or unable to use an adequate contraceptive method to avoid pregnancy for the entire study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral tubectomy, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as amenorrhea for ≥ 12 consecutive months without another cause.
- Clinically acceptable contraceptive methods for this study: intrauterine devices (e.g., loop), physical barrier method (e.g., diaphragm, uterine cap, condom) with chemical barrier method (e.g., spermicide), sterile partner, practicing abstinence.
- WOCBP who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.
- WOCBP who are pregnant or breastfeeding.
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- WOCBP with a positive pregnancy test prior to randomization.
- Males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study.
- Presence of uncontrolled or severe medical illness.
- Presence of a disease that require surgery at any time during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind/Open-label, Placebo/Active-controlled, Single/Multiple Dose, Parallel, Phase 1/2a Trial to Evaluate the Safety, Tolerability, PK , PD of YH12852 in Healthy Subjects and Patients With Functional Constipation
A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose, parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation
- Conditions
- Functional Constipation
- Being tested
- YH12852 IR 0.05mg, YH12852 IR 0.1mg, YH12852 IR 0.3mg, YH12852 IR 0.5mg, YH12852 IR 1mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH12852 IR 0.05mgDrug
YH12852 IR 0.1mgDrug
YH12852 IR 0.3mgDrug
YH12852 IR 0.5mgDrug
YH12852 IR 1mgDrug
YH12852 IR 2mgDrug
YH12852 IR 3mgDrug
YH12852 DR1 0.5mgDrug
YH12852 DR1 1mgDrug
YH12852 DR1 2mgDrug
YH12852 DR1 4mgDrug
YH12852 DR2 8mgDrug
Prucalopride 2mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| YH12852 IR 0.05mg | Experimental | Once daily Receives: Drug: YH12852 IR 0.05mg |
| YH12852 IR 0.1mg | Experimental | Once daily Receives: Drug: YH12852 IR 0.1mg |
| YH12852 IR 0.3mg | Experimental | Once daily Receives: Drug: YH12852 IR 0.3mg |
| YH12852 IR 0.5mg | Experimental | Once daily Receives: Drug: YH12852 IR 0.5mg |
| YH12852 IR 1mg | Experimental | Once daily Receives: Drug: YH12852 IR 1mg |
| YH12852 IR 2mg | Experimental | Once daily Receives: Drug: YH12852 IR 2mg |
| YH12852 IR 3mg | Experimental | Once daily Receives: Drug: YH12852 IR 3mg |
| YH12852 DR1 0.5mg | Experimental | Once daily Receives: Drug: YH12852 DR1 0.5mg |
| YH12852 DR1 1mg | Experimental | Once daily Receives: Drug: YH12852 DR1 1mg |
| YH12852 DR1 2mg | Experimental | Once daily Receives: Drug: YH12852 DR1 2mg |
| YH12852 DR1 4mg | Experimental | Once daily Receives: Drug: YH12852 DR1 4mg |
| YH12852 DR2 8mg | Experimental | Once daily Receives: Drug: YH12852 DR2 8mg |
| Prucalopride 2mg | Active comparator | Once daily Receives: Drug: Prucalopride 2mg |
| Placebo | Placebo comparator | Once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Measured: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Measured: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Measured: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
C(IR multiple dose cohort)
CD5, CD10, CD12, CD13
Measured: Day 5, 10, 12 and 13
Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Measured: Day 14
Cmax,ss (DR single dose cohort)
Measured: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
AUClast (DR single dose cohort)
Measured: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
C(DR multiple dose cohort and Multiple low-dose IR cohort)
CD5, CD13, CD14
Measured: Day 5, 13 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Lee, MD, PhD, Principal investigator, Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538367
- Sponsor's protocol ID
- YH12852-102
- Status last verified
- Oct 2016
- First submitted
- 21 Aug 2015
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind/Open-label, Placebo/Active-controlled, Single/Multiple Dose, Parallel, Phase 1/2a Trial to Evaluate the Safety, Tolerability, PK , PD of YH12852 in Healthy Subjects and Patients With Functional Constipation
- ClinicalTrials.gov ID
- NCT02538367
- Acronym / sponsor ID
- YH12852-102
- Conditions
- Functional Constipation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose, parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| YH12852 IR 0.05mg | Experimental | Drug: YH12852 IR 0.05mgOnce daily |
| YH12852 IR 0.1mg | Experimental | Drug: YH12852 IR 0.1mgOnce daily |
| YH12852 IR 0.3mg | Experimental | Drug: YH12852 IR 0.3mgOnce daily |
| YH12852 IR 0.5mg | Experimental | Drug: YH12852 IR 0.5mgOnce daily |
| YH12852 IR 1mg | Experimental | Drug: YH12852 IR 1mgOnce daily |
| YH12852 IR 2mg | Experimental | Drug: YH12852 IR 2mgOnce daily |
| YH12852 IR 3mg | Experimental | Drug: YH12852 IR 3mgOnce daily |
| YH12852 DR1 0.5mg | Experimental | Drug: YH12852 DR1 0.5mgOnce daily |
| YH12852 DR1 1mg | Experimental | Drug: YH12852 DR1 1mgOnce daily |
| YH12852 DR1 2mg | Experimental | Drug: YH12852 DR1 2mgOnce daily |
| YH12852 DR1 4mg | Experimental | Drug: YH12852 DR1 4mgOnce daily |
| YH12852 DR2 8mg | Experimental | Drug: YH12852 DR2 8mgOnce daily |
| Prucalopride 2mg | Active comparator | Drug: Prucalopride 2mgOnce daily |
| Placebo | Placebo comparator | Drug: PlaceboOnce daily |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects must be willing and able to provide written informed consent.
- BMI within the range 18 to 25 kg/m2.
Key exclusion criteria (10 listed)
- History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.
- Clinically significant lab/ECG abnormalities in the opinion of the investigator.
- WOCBP who are unwilling or unable to use an adequate contraceptive method to avoid pregnancy for the entire study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral tubectomy, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as amenorrhea for ≥ 12 consecutive months without another cause.
- Clinically acceptable contraceptive methods for this study: intrauterine devices (e.g., loop), physical barrier method (e.g., diaphragm, uterine cap, condom) with chemical barrier method (e.g., spermicide), sterile partner, practicing abstinence.
- WOCBP who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YH12852 IR 0.05mg | Drug | YH12852 IR 0.05mg |
| YH12852 IR 0.1mg | Drug | YH12852 IR 0.1mg |
| YH12852 IR 0.3mg | Drug | YH12852 IR 0.3mg |
| YH12852 IR 0.5mg | Drug | YH12852 IR 0.5mg |
| YH12852 IR 1mg | Drug | YH12852 IR 1mg |
| YH12852 IR 2mg | Drug | YH12852 IR 2mg |
| YH12852 IR 3mg | Drug | YH12852 IR 3mg |
| YH12852 DR1 0.5mg | Drug | YH12852 DR1 0.5mg |
| YH12852 DR1 1mg | Drug | YH12852 DR1 1mg |
| YH12852 DR1 2mg | Drug | YH12852 DR1 2mg |
| YH12852 DR1 4mg | Drug | YH12852 DR1 4mg |
| YH12852 DR2 8mg | Drug | YH12852 DR2 8mg |
| Prucalopride 2mg | Drug | Prucalopride 2mg |
| Placebo | Drug | Placebo |
Primary outcome
Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
C(IR multiple dose cohort)
Time frame: Day 5, 10, 12 and 13
CD5, CD10, CD12, CD13
Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time frame: Day 14
Cmax,ss (DR single dose cohort)
Time frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
AUClast (DR single dose cohort)
Time frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
C(DR multiple dose cohort and Multiple low-dose IR cohort)
Time frame: Day 5, 13 and 14
CD5, CD13, CD14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Lee, MD, PhD principal investigator
Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YH12852 IR 0.05mg, YH12852 IR 0.1mg and YH12852 IR 0.3mg in people with Functional Constipation, run by Yuhan Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort) (time frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.