Last updated: 11/04/2018 10:16:19
A Study Investigating Blood Concentrations Of Rosuvastatin When Co-administered With GW856553 In Healthy Men
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, single blind, repeat dose, placebo-controlled, single-period, parallel group study to investigate the safety, tolerability and potential pharmacokinetic interactions between GW856553 and Rosuvastatin (10mg), when co-administered in healthy adult male subjects
Trial description: This study is being conducted to provide initial safety and tolerability data as well as to provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered in healthy male adults
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
PK blood draws at days 14 and 28
Timeframe: days 14 and 28
Secondary outcomes:
The primary pharmacokinetic endpoints of interest are AUC(0-τ) and Cmax for rosuvastatin
Timeframe: days 14, 15, 28
The secondary pharmacokinetic endpoints of interest are Tmax and t1/2 for rosuvastatin
Timeframe: days 14, 15, 28
Measurement of alanine aminotransferase (ALT) and maximum change from baseline in ALT in all subjects
Timeframe: days -1, 13, 14, 16, 18, 20, 22, 24, 26, 28, follow up
Clinical safety data from spontaneous adverse event reporting, 12-lead ECG recording, vital sign measurement, nursing/physician observation and safety laboratory examination.
Timeframe: days -1, 13, 14, 16, 22, 26, 28, follow up
Analysis of LPS induction of IL-1b, IL-6, IL-8 and TNFa, as well as additional biomarkers, as data permit.
Timeframe: day 1, 14, 21, 28
Interventions:
Enrollment:
44
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
- Inclusion criteria:
- Healthy adult males, 18-55 years of age, inclusive
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Healthy adult males, 18-55 years of age, inclusive
- 50Kg >body weight <120Kg
- Body Mass Index (BMI): 19-30
- Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.
- Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
- Positive HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody, or other chronic hepatic disorders at screening.
- Subjects with chronic infections such as gingivitis, periodontitis, prostatitis, gastritis, urinary track infections, or any active diseases, including tuberculosis or a history of active tuberculosis.
- Subjects with any acute infection, symptoms suggestive of sinusitis or significant trauma (burns, fractures).
- History of alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of 80 proof distilled spirits) within 6 months of screening.
- Positive urine drug (including cotinine) and/or alcohol at screening.
- A history of smoking within the 3 months prior to screening.
- Use of prescription or non-prescription drugs, including (but not limited to) vitamins, herbal and dietary supplements (including St. John’s Wort) within 7 days (or 14 days if the drug is a potential drug inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication. An exception is acetaminophen which is allowed at doses of ≤ 2g/day.
- Participation in a clinical study where the subject has received a drug or new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
- The subject has been exposed to more than four new chemical entities within 12 months prior to the first day of dosing.
- Consumption of any fruit juices (including grapefruit juice) within 7 days prior to the first dose of study medication.
- A history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology.
- History of increased liver function tests (ALT, AST) above upper limit of normal in the past 6 months and/or liver function tests (bilirubin, ALT, AST) above upper limit of normal at Screening.
- A known history of Gilbert's Syndrome.
- History of myopathy or rhabdomyolysis.
- QTc interval > 450msec.
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception, such as: an intrauterine devise (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if the woman could become pregnant from the first dose of study medication until completion of follow-up procedures.
- Donation of blood in excess of 500 mL within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Hypersensitivity to rosuvastatin or any component of the rosuvastatin formulation utilised in this study.
Must be within 20% of the ideal weight based on height and body frame Exclusion criteria:
Trial location(s)
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-04-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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