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Completed

NCT Number: NCT02538367

Phase 1/2a Trial 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

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Key information

Conditions

Functional Constipation

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

YH12852 IR 0.05mg

Drug

YH12852 IR 0.1mg

Drug

YH12852 IR 0.3mg

Drug

YH12852 IR 0.5mg

Drug

YH12852 IR 1mg

Drug

YH12852 IR 2mg

Drug

YH12852 IR 3mg

Drug

YH12852 DR1 0.5mg

Drug

YH12852 DR1 1mg

Drug

YH12852 DR1 2mg

Drug

YH12852 DR1 4mg

Drug

YH12852 DR2 8mg

Drug

Prucalopride 2mg

Drug

Placebo

Drug

Primary outcomes

  1. Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort)

    Time frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose

  2. 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

  3. Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)

    Time frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose

  4. C(IR multiple dose cohort)

    Time frame: Day 5, 10, 12 and 13

    CD5, CD10, CD12, CD13

  5. Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)

    Time frame: Day 14

  6. Cmax,ss (DR single dose cohort)

    Time frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose

  7. AUClast (DR single dose cohort)

    Time frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose

  8. C(DR multiple dose cohort and Multiple low-dose IR cohort)

    Time frame: Day 5, 13 and 14

    CD5, CD13, CD14

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 2, 2015
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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