Overview

Phase I Clinical Trial in Healthy Male Volunteers

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hutchison Medipharma Limited
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;

- Tobacco or nicotine use within the 6 months prior to first dose until the follow-up
assessment, or a positive urine screen for cotinine;

- Hypersensitivity or idiosyncratic reaction to compounds related to the study drug;

- Use of substances known to be strong inhibitors or inducers of cytochrome P450 enzymes
(eg, macrolides, calcium channel blockers, ritonavir, rifampin, St. John's Wort, etc.)
within 30 days prior to the first dose;

- Use of prescription or non-prescription drugs, including high-dose vitamins, herbal
and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to
the first dose of study medication (except for strong inhibitors or inducers of
cytochrome P450 enzymes);

- Consumption of food or beverage containing grapefruit or cranberry within 7 days prior
to the dose of study medication;

- Recent significant changes in body weight due to dieting or nutritional treatment;

- Donation of whole blood in excess of 500 mL within 56 days prior to checkin;

- Plasma donation within 7 days prior to check-in;

- Subject participated in an investigational clinical study within 30 days prior to the
first dosing, or days calculated as ten times the half-life of the compound which the
subject was treated with, whichever is longer. Factors other than the half-life of the
compound, such as accumulation of tissue, muscle or organ, should also be considered
for the enrollment;

- Exposure to 4 or more investigational products within 12 months prior to the first
dosing day; Hutchison MediPharma Ltd. Clinical Study Protocol HMPL-004-1002
Confidential & Proprietary 28 Final 20 July 2011

- Positive screen for HIV, hepatitis B, and/or hepatitis C at screening;

- Positive urine screen for drugs of abuse at screening or check-in; and

- Any condition that, in the opinion of the Principal Investigator, would complicate or
compromise the study, or the well-being of the subject 4.2.3 General and Dietary
Restrictions

The following items are not to be consumed for 48 hours (2 days) prior to the first dose
until the last scheduled blood sample collection of the study:

- Caffeine/xanthine such as coffee, tea, chocolate, and all caffeine containing soft
drinks or energy drinks;

- Alcoholic beverages and/or other alcohol containing products; and

- Any foods containing poppy seeds.

The following items are not to be consumed for 14 days prior to the first dose and
throughout the study until the last scheduled blood sample collection:

• Grapefruit, pomelo, cranberry, or grapefruit, pomelo, or cranberry-containing products.
While in the CPU, subjects will not be allowed additional sugar in beverages or on cereal,
though limited use of other sweeteners is allowed.