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Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation

NCT ID: NCT02538367

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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YH12852 IR 0.05mg

Once daily

Group Type EXPERIMENTAL

YH12852 IR 0.05mg

Intervention Type DRUG

YH12852 IR 0.1mg

Once daily

Group Type EXPERIMENTAL

YH12852 IR 0.1mg

Intervention Type DRUG

YH12852 IR 0.3mg

Once daily

Group Type EXPERIMENTAL

YH12852 IR 0.3mg

Intervention Type DRUG

YH12852 IR 0.5mg

Once daily

Group Type EXPERIMENTAL

YH12852 IR 0.5mg

Intervention Type DRUG

YH12852 IR 1mg

Once daily

Group Type EXPERIMENTAL

YH12852 IR 1mg

Intervention Type DRUG

YH12852 IR 2mg

Once daily

Group Type EXPERIMENTAL

YH12852 IR 2mg

Intervention Type DRUG

YH12852 IR 3mg

Once daily

Group Type EXPERIMENTAL

YH12852 IR 3mg

Intervention Type DRUG

YH12852 DR1 0.5mg

Once daily

Group Type EXPERIMENTAL

YH12852 DR1 0.5mg

Intervention Type DRUG

YH12852 DR1 1mg

Once daily

Group Type EXPERIMENTAL

YH12852 DR1 1mg

Intervention Type DRUG

YH12852 DR1 2mg

Once daily

Group Type EXPERIMENTAL

YH12852 DR1 2mg

Intervention Type DRUG

YH12852 DR1 4mg

Once daily

Group Type EXPERIMENTAL

YH12852 DR1 4mg

Intervention Type DRUG

YH12852 DR2 8mg

Once daily

Group Type EXPERIMENTAL

YH12852 DR2 8mg

Intervention Type DRUG

Prucalopride 2mg

Once daily

Group Type ACTIVE_COMPARATOR

Prucalopride 2mg

Intervention Type DRUG

Placebo

Once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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YH12852 IR 0.05mg

Intervention Type DRUG

YH12852 IR 0.1mg

Intervention Type DRUG

YH12852 IR 0.3mg

Intervention Type DRUG

YH12852 IR 0.5mg

Intervention Type DRUG

YH12852 IR 1mg

Intervention Type DRUG

YH12852 IR 2mg

Intervention Type DRUG

YH12852 IR 3mg

Intervention Type DRUG

YH12852 DR1 0.5mg

Intervention Type DRUG

YH12852 DR1 1mg

Intervention Type DRUG

YH12852 DR1 2mg

Intervention Type DRUG

YH12852 DR1 4mg

Intervention Type DRUG

YH12852 DR2 8mg

Intervention Type DRUG

Prucalopride 2mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects must be willing and able to provide written informed consent.
2. BMI within the range 18 to 25 kg/m2.

Exclusion Criteria

1. History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.
2. Clinically significant lab/ECG abnormalities in the opinion of the investigator.
3. 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.
4. WOCBP who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.
5. WOCBP who are pregnant or breastfeeding.
6. WOCBP with a positive pregnancy test prior to randomization.
7. Males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study.
8. Presence of uncontrolled or severe medical illness.
9. Presence of a disease that require surgery at any time during the study.
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YH12852-102

Identifier Type: -

Identifier Source: org_study_id