Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.
Overview
- Phase
- Phase 1
- Intervention
- HMPL-011 tablets
- Conditions
- Inflammatory Bowel Diseases
- Sponsor
- Hutchison Medipharma Limited
- Enrollment
- 24
- Primary Endpoint
- Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fasted States
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.
Detailed Description
Eligible subjects will randomly recieve 1200 mg tablets (600 mg tablet X 2) or 1200 mg capsules (200 mg capsule X 6) of HMPL-011 under fed and fed circumstance in part 1. In part 2, eight subjects will be enrolled and given 800 mg tablets (400 mg/tablet X 2) every 8 hours daily for 6 days (morning dose only on Day 6).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the study:
- •Healthy adult male and female subjects, 18-70 years of age, inclusive, at the time of signing the informed consent;
- •Body weight ≥ 50 kg and body mass index (BMI) within the range 19-30 kg/m2, inclusive, at screening;
- •Medically healthy subjects with clinically insignificant screening and check-in results (medical histories, 12-lead ECG, physical exam and laboratory tests);
- •Female subjects of childbearing potential with a negative urine pregnancy test at screening who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control from the first dose until 7 days following the last administration of study drug;
- •Male subjects must agree to use barrier contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) from first dose until 7 days following the last administration of study drug; and
- •Subjects are able to understand and to give their signed informed consent before any trial related procedures being performed.
Exclusion Criteria
- •Subjects are excluded from participation in the study if any of the following criteria apply:
- •Subjects with, or a history of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric or other major disorder;
- •Presence or history of GI, hepatic or renal disease or any other condition (including surgery) known to interfere with the absorption, distribution, metabolism or excretion of medicines; Hutchison MediPharma Ltd. Clinical Study Protocol HMPL-004-1002 Confidential \& Proprietary 27 Final 20 July 2011
- •Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 bpm after one repeat at screening or check-in;
- •Abnormal ECGs at screening
- •History of clinically significant drug and/or food allergies as determined by the Principal Investigator (PI);
- •Subjects will be excluded if they experience arrhythmia of any clinical significance;
- •Subject is not willing to abstain from alcohol for 48 hours prior to the start of the first dose until completion of the post-study follow-up assessments;
- •Any history (within 2 years) or current diagnosed alcoholism defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.);
- •Recent history or current diagnosed drug abuse;
Arms & Interventions
HMPL-011 tablets
A sigle total oral dose of 1200 mg tablets (600 mg tablet X 2)
Intervention: HMPL-011 tablets
HMPL-011 capsules
A sigle total oral dose of 1200 mg capsules (200 mg tablet X 6)
Intervention: HMPL-011 capsules
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fasted States
Time Frame: 72 hours
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fed States
Time Frame: 72 hours
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Steady State concentration of HMPL-011
Time Frame: 5 weeks
Steady State concentration of HMPL-011 will be caculated based on Ctrough
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets vs capsules in fed States.
Time Frame: 72 hours
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets vs capsules in fasted States.
Time Frame: 72 hours
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
Secondary Outcomes
- Overall incidence of TEAEs(5 weeks)