Overview

Phase I Study of GW642444M in Healthy Japanese Male Subjects

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
Male
Summary
This is a randomized, double blind, placebo controlled, parallel-group, 7 day repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose of GW642444M from a novel dry powder device in healthy Japanese male subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
GlaxoSmithKline
Criteria
Inclusion Criteria:

1. Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy
subjects are defined as individuals who are free from clinically significant illness
or disease as determined by their medical history, physical examination, laboratory
studies, and other tests.

2. Body weight ≥ 50kg and BMI within the range 18.5-25.0kg/m2 inclusive.

3. Non-smokers (never smoked or not smoking for >6 months with <10 pack years history
(Pack years = (cigarettes per day smoked/20) x number of years smoked))

4. Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).

5. Clinical laboratory tests data obtained at screening meet the following:

AST(GOT), ALT(GPT), total-bilirubin: below the upper limit of the normal ranges

6. Serum potassium and glucose within normal range at screening

7. Normal 12-lead EGC finding at screening; QTc interval <450msec

8. A mean heart rate within the range 40-90 beats per minute (bpm) inclusive at
screening.

9. A mean blood pressure lower than 140/90mmHg at screening.

10. Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.

11. Capable of using the novel dry powder inhaler.

Exclusion Criteria:

1. The subject has any clinically relevant abnormality on medical examination, vital
sign, clinical laboratory test or medical history at screening in the medical opinion
of the investigator or the subject has a medical history that is not considered as
eligible for inclusion in this study by the investigator.

2. The subject is currently participating in another clinical study or post-marketing
study in which the subject is or will be exposed to an investigational or a
non-investigational drug or device.

3. The subject has participated in a clinical study with an investigational or a
non-investigational drug or device during the previous 4 months.

4. A history of breathing problems (i.e. history of asthmatic symptomatology, asthma in
childhood).

5. The subject has an allergy for any drug or idiosyncrasy

6. The subject has a known allergy or hypersensitivity to milk protein or the excipients
lactose monohydrate and magnesium stearate.

7. The subject has a history or current conditions of drug abuse or alcoholism.

8. History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink=5
ounces (150mL) of wine or 350mL of beer or 1.5 ounces (45mL) of 80 proof distilled
spirits) within 6 month of screening.

9. The subject is positive for urine drug screening.

10. Use of prescription or non-prescription drugs, including CYP3A/PGP inhibitor,
vitamins, herbal and dietary supplements (including St John'sWort) within 14 days
prior to the first dose of study medication.

11. The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1
antibody.

12. The subject has donated a unit of blood ">400mL" within the previous 4 months or
">200mL" within the previous 1 month.