AtherosclerosisPhase 1NCT01751074
To Estimate the Potential Effects of Repeat Doses of Darapladib on the Pharmacokinetics (PK) of Rosuvastatin as Well as Evaluating Safety and Tolerability in Healthy Volunteers
A Phase 1 study testing Rosuvastatin 10 mg and Darapladib 160 mg in people with Atherosclerosis, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The potential for a drug interaction between Darapladib and Rosuvastatin is felt to be low and it would be helpful to quantify this risk in man in order to guide prescribing physicians. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Rosuvastatin 10 mg and Darapladib 160 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2012to 14 Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 20 and 64 years of age inclusive, at the time of signing the informed consent.
- Subject must be of Caucasian or of Far-East Asian Descent. Far -East Asian is defined as a person of self-reported Asian ancestry including that of Japanese, Korean or Chinese descent (which includes Taiwanese subjects) [for Part B only].
- Far East Asian subjects must have been born in their native countries and have resided less than 10 years outside their native countries [for Part B only].
- Far East Asian subjects must have maintained a lifestyle, including diet, without significant change since leaving his/her native country [for Part B only].
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone > 40 milliliter of urine (MlU)/ milliliter (mL) and estradiol < 40 picogram/mL (<147 picomoles/liter is confirmatory] or Child-bearing potential and is abstinent or agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until follow-up.
- Body mass index within the range 19 to 37 kilogram/meter^2 (inclusive)
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- A positive pre-study drug/alcohol screen.
- A positive test for human immune virus (HIV) antibody
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: Thirty days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
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- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in a previous study or donor bank would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Requiring the use of oral or injectable strong cytochrom P3A4 inhibitors.
- Pregnant females as determined by positive human chorionic gonadotropin test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or history of heparin-induced thrombocytopenia.
- History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions Clinical criteria for diagnosing anaphylaxis or severe allergic responses.
- Consumption of grapefruit or grapefruit juice >8 ounce within 7 days prior to the first dose of study medication
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Glendale, California, 91206
About this study
Official title: A Two-Part, Open-label, Sequential, Double Cohort, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Rosuvastatin When Co Administered With Darapladib in Healthy Adult Subjects
The potential for a drug interaction between Darapladib and Rosuvastatin is felt to be low and it would be helpful to quantify this risk in man in order to guide prescribing physicians. The primary aims of this study are to estimate the potential effects of repeat doses of Darapladib on the PK of Rosuvastatin as well as evaluating safety and tolerability. Two part approaches are planned for this study. Part A of the study will examine the effects of repeat doses Darapladib on the PK of Rosuvastatin in healthy volunteers of Caucasian descent. Based on whether a significant increase in Rosuvastatin exposure is observed in Caucasians in Part A, a decision will be made regarding whether to proceed with a conditional Part B to examine this effect in healthy volunteers of Far-East Asian descent.
In both parts, subjects will receive Rosuvastatin 10 milligrams (mg) once daily (QD) for 1 day during the first treatment period (Treatment Period 1), followed by a 4 day PK sampling period/wash-out. Subjects will then receive darapladib 160 mg QD for the next 10 days with 24-hour PK sampling on the last day (Day 14 of the study). Immediately following this, all subjects will then receive the combination of Darapladib 160 mg and Rosuvastatin 10 mg for 1 day and continued Darapladib dosing of 160 mg QD for additional 3 days (Treatment Period 2) while blood samples are collected to assess Rosuvastatin PK. Plasma samples collected on Day 15 will be analyzed for both Rosuvastatin and Darapladib concentrations.
Read more
Subjects will be required to return to the unit approximately 10 to 14 days following the last dose of study medication for a clinic visit for assessments and then will return again at 35 ±7 days following the last dose for the final follow-up visit of the study. The duration of each subject's participation in the study from screening to follow-up will be approximately three months.
Approximately 18 evaluable subjects will be enrolled in Part A and another 18 subjects will be enrolled in Part B (if conducted) to complete dosing and all assessments.
- Conditions
- Atherosclerosis
- Being tested
- Rosuvastatin 10 mg, Darapladib 160 mg
- Keywords
- Drug interaction, rosuvastatin, healthy volunteer, Lp-PLA2, atherosclerosis, darapladib, pharmacokinetics.
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 10 mgDrug
Also called Crestor
Enteric coated tablet will be administered orally as a single dose once in Treatment Period 1 (Day 1) and Treatment Period 2 (Day 15).
Darapladib 160 mgDrug
Enteric coated tablet will be administered orally as once daily for 14 days in Treatment Period 2 only (Day 5 to Day 18).
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | All subjects will be of Caucasian descent and will receive single dose of Rosuvastatin 10 mg for 1 day (Day 1) during treatment period 1, then will receive Darapladib 160 mg once daily (QD) for 10 days (Day 5 to 14) in treatment period 2. Immediately following this, all subjects will receive the combination of Darapladib 160 mg and Rosuvastatin 10 mg for 1 day (Day 15) and continued Darapladib dosing of 160 mg QD for additional 3 days (Days 16 to 18) in treatment period 2. Receives: Drug: Rosuvastatin 10 mg; Drug: Darapladib 160 mg |
| Part B | Experimental | The decision to initiate Part B will be made by the GSK study team based on an evaluation of data from Part A. Part B will consist of a cohort of healthy subjects of Far-East Asian descent and will be conducted similar to Part A. Receives: Drug: Rosuvastatin 10 mg; Drug: Darapladib 160 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single dose PK of Rosuvastatin assessed by AUC (0-infinity) or AUC (0-t) when co-administered with darapladib and when administered alone.
To evaluate the single dose PK of Rosuvastatin, area under the concentration-time curve from time zero extrapolated to infinite time (AUC [0-infinity]) or area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC [0-t]) will be assessed.
Measured: 09 days. Blood samples will be collected on Day 1 to 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 hours [hrs] post dose) and on Day 15 to 18 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24, 36, 48, 72, and 96 hrs post dose).
Single dose PK of Rosuvastatin assessed by Cmax when co-administered with darapladib and when administered alone.
To evaluate the single dose PK of Rosuvastatin, maximum observed concentration (Cmax) will be assessed.
Measured: 09 days. Blood samples will be collected on Day 1 to 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 hours [hrs] post dose) and on Day 15 to 18 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24, 36, 48, 72, and 96 hrs post dose).
Single dose PK of Rosuvastatin assessed by Tmax and T1/2 (as data permit) when co-administered with darapladib and when administered alone.
To evaluate the single dose PK of Rosuvastatin, time of occurrence of Cmax (Tmax), and terminal phase half-life (T1/2) will be assessed.
Measured: 09 days. Blood samples will be collected on Day 1 to 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 hours [hrs] post dose) and on Day 15 to 18 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24, 36, 48, 72, and 96 hrs post dose).
Secondary outcomes (9)
Single dose Rosuvastatin PK compared between Caucasian subjects (Part A) and if performed, Asian subjects (Part B).
Single dose Rosuvastatin PK will be assessed by comparison of AUC (0-infinity), or AUC (0-t), Cmax, Tmax and T1/2 as data permit.
Measured: 05 days. Blood samples will be collected on Day 1 to Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours [hrs] post dose).
Rosuvastatin PK when co-administered with repeat doses of Darapladib compared between Caucasian subjects (Part A) and if performed, Asian subjects (Part B).
Rosuvastatin PK when co-administered with repeat doses of Darapladib will be assessed by comparison of AUC (0-infinity), or AUC (0-t), Cmax, Tmax and T1/2 as data permit.
Measured: 01 day. Blood samples will be collected on Day 15 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hrs post dose) of each part.
Repeat doses PK of Darapladib compared between Caucasian subjects (Part A) and if performed, Asian subjects (Part B).
Repeat doses PK of Darapladib assessed by comparison of area under the concentration-time curve over the dosing interval (AUC [0-tau]), Cmax, Tmax and T1/2 as data permit
Measured: 02 days. Blood samples will be collected on Day 13 (pre-dose), and Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hrs post-dose) of each part.
Repeat doses PK of Darapladib assessed by AUC (0-tau) when co-administered with single dose of Rosuvastatin and when administered alone.
To evaluate the repeat doses PK of Darapladib, AUC (0-tau), will be assessed when repeat doses of Darapladib given with single dose of Rosuvastatin and when given alone.
Measured: 03 days. Blood samples will be collected on Day 13 (pre-dose), Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hrs post-dose) and Day 15 (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hrs post dose).
Repeat doses PK of Darapladib assessed by Cmax when co-administered with single dose Rosuvastatin and when administered alone
To evaluate the repeat doses PK of Darapladib, Cmax will be assessed when repeat doses of Darapladib given with single dose of Rosuvastatin and when given alone.
Measured: 03 days. Blood samples will be collected on Day 13 (pre-dose), Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hrs post-dose) and Day 15 (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hrs post dose).
Repeat doses PK of Darapladib assessed by Tmax, and T1/2 (as data permit) when co-administered with Rosuvastatin and when administered alone
To evaluate the repeat doses PK of Darapladib, Tmax, and T1/2 will be assessed when repeat doses of Darapladib given with single dose of Rosuvastatin and when given alone.
Measured: 03 days. Blood samples will be collected on Day 13 (pre-dose), Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hrs post-dose) and Day 15 (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hrs post dose).
Safety and tolerability of darapladib when co-administered with Rosuvastatin assessed by incidence and severity of adverse events
Adverse events (AEs) will be collected from the start of study treatment and until the follow-up contact. Intensity of AEs will be categorized as mild, moderate or severe
Measured: Up to 60 days
Safety and tolerability of darapladib when co-administered with Rosuvastatin assessed by vital signs
Vital signs measurement will include systolic and diastolic blood pressure and pulse rate.
Measured: Up to 60 days
Safety and tolerability of darapladib when co-administered with Rosuvastatin assessed by clinical laboratory data
Clinical laboratory tests include hematology, clinical chemistry, urinalysis and additional parameters.
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study start17 Dec 2012
- Primary completion14 Mar 2013
- Study completion14 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751074
- Sponsor's protocol ID
- 115677
- Status last verified
- Jul 2017
- First submitted
- 13 Dec 2012
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Open-label, Sequential, Double Cohort, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Rosuvastatin When Co Administered With Darapladib in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01751074
- Acronym / sponsor ID
- 115677
- Conditions
- Atherosclerosis
- Keywords
- Drug interaction, rosuvastatin, healthy volunteer, Lp-PLA2, atherosclerosis, darapladib, pharmacokinetics.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2012 (actual)
- Primary completion
- 14 Mar 2013 (actual)
- Study completion
- 14 Mar 2013 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The potential for a drug interaction between Darapladib and Rosuvastatin is felt to be low and it would be helpful to quantify this risk in man in order to guide prescribing physicians. The primary aims of this study are to estimate the potential effects of repeat doses of Darapladib on the PK of Rosuvastatin as well as evaluating safety and tolerability. Two part approaches are planned for this study. Part A of the study will examine the effects of repeat doses Darapladib on the PK of Rosuvastatin in healthy volunteers of Caucasian descent. Based on whether a significant increase in Rosuvastatin exposure is observed in Caucasians in Part A, a decision will be made regarding whether to proceed with a conditional Part B to examine this effect in healthy volunteers of Far-East Asian descent.
In both parts, subjects will receive Rosuvastatin 10 milligrams (mg) once daily (QD) for 1 day during the first treatment period (Treatment Period 1), followed by a 4 day PK sampling period/wash-out. Subjects will then receive darapladib 160 mg QD for the next 10 days with 24-hour PK sampling on the last day (Day 14 of the study). Immediately following this, all subjects will then receive the combination of Darapladib 160 mg and Rosuvastatin 10 mg for 1 day and continued Darapladib dosing of 160 mg QD for additional 3 days (Treatment Period 2) while blood samples are collected to assess Rosuvastatin PK. Plasma samples collected on Day 15 will be analyzed for both Rosuvastatin and Darapladib concentrations.
Subjects will be required to return to the unit approximately 10 to 14 days following the last dose of study medication for a clinic visit for assessments and then will return again at 35 ±7 days following the last dose for the final follow-up visit of the study. The duration of each subject's participation in the study from screening to follow-up will be approximately three months.
Approximately 18 evaluable subjects will be enrolled in Part A and another 18 subjects will be enrolled in Part B (if conducted) to complete dosing and all assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Rosuvastatin 10 mg, Drug: Darapladib 160 mgAll subjects will be of Caucasian descent and will receive single dose of Rosuvastatin 10 mg for 1 day (Day 1) during treatment period 1, then will receive Darapladib 160 mg once daily (QD) for 10 days (Day 5 to 14) in treatment period 2. Immediately following this, all subjects will receive the combination of Darapladib 160 mg and Rosuvastatin 10 mg for 1 day (Day 15) and continued Darapladib dosing of 160 mg QD for additional 3 days (Days 16 to 18) in treatment period 2. |
| Part B | Experimental | Drug: Rosuvastatin 10 mg, Drug: Darapladib 160 mgThe decision to initiate Part B will be made by the GSK study team based on an evaluation of data from Part A. Part B will consist of a cohort of healthy subjects of Far-East Asian descent and will be conducted similar to Part A. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 20 and 64 years of age inclusive, at the time of signing the informed consent.
- Subject must be of Caucasian or of Far-East Asian Descent. Far -East Asian is defined as a person of self-reported Asian ancestry including that of Japanese, Korean or Chinese descent (which includes Taiwanese subjects) [for Part B only].
- Far East Asian subjects must have been born in their native countries and have resided less than 10 years outside their native countries [for Part B only].
- Far East Asian subjects must have maintained a lifestyle, including diet, without significant change since leaving his/her native country [for Part B only].
Key exclusion criteria (18 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- A positive pre-study drug/alcohol screen.
- A positive test for human immune virus (HIV) antibody
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 10 mgAlso: CrestorEnteric coated tablet will be administered orally as a single dose once in Treatment Period 1 (Day 1) and Treatment Period 2 (Day 15). | Drug | Part A, Part B |
| Darapladib 160 mgEnteric coated tablet will be administered orally as once daily for 14 days in Treatment Period 2 only (Day 5 to Day 18). | Drug | Part A, Part B |
Primary outcome
Single dose PK of Rosuvastatin assessed by AUC (0-infinity) or AUC (0-t) when co-administered with darapladib and when administered alone.
Time frame: 09 days. Blood samples will be collected on Day 1 to 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 hours [hrs] post dose) and on Day 15 to 18 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24, 36, 48, 72, and 96 hrs post dose).
To evaluate the single dose PK of Rosuvastatin, area under the concentration-time curve from time zero extrapolated to infinite time (AUC [0-infinity]) or area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC [0-t]) will be assessed.
Single dose PK of Rosuvastatin assessed by Cmax when co-administered with darapladib and when administered alone.
Time frame: 09 days. Blood samples will be collected on Day 1 to 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 hours [hrs] post dose) and on Day 15 to 18 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24, 36, 48, 72, and 96 hrs post dose).
To evaluate the single dose PK of Rosuvastatin, maximum observed concentration (Cmax) will be assessed.
Single dose PK of Rosuvastatin assessed by Tmax and T1/2 (as data permit) when co-administered with darapladib and when administered alone.
Time frame: 09 days. Blood samples will be collected on Day 1 to 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 hours [hrs] post dose) and on Day 15 to 18 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24, 36, 48, 72, and 96 hrs post dose).
To evaluate the single dose PK of Rosuvastatin, time of occurrence of Cmax (Tmax), and terminal phase half-life (T1/2) will be assessed.
9 secondary outcomes
Single dose Rosuvastatin PK compared between Caucasian subjects (Part A) and if performed, Asian subjects (Part B).
Time frame: 05 days. Blood samples will be collected on Day 1 to Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours [hrs] post dose).
Rosuvastatin PK when co-administered with repeat doses of Darapladib compared between Caucasian subjects (Part A) and if performed, Asian subjects (Part B).
Time frame: 01 day. Blood samples will be collected on Day 15 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hrs post dose) of each part.
Repeat doses PK of Darapladib compared between Caucasian subjects (Part A) and if performed, Asian subjects (Part B).
Time frame: 02 days. Blood samples will be collected on Day 13 (pre-dose), and Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hrs post-dose) of each part.
Repeat doses PK of Darapladib assessed by AUC (0-tau) when co-administered with single dose of Rosuvastatin and when administered alone.
Time frame: 03 days. Blood samples will be collected on Day 13 (pre-dose), Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hrs post-dose) and Day 15 (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hrs post dose).
Repeat doses PK of Darapladib assessed by Cmax when co-administered with single dose Rosuvastatin and when administered alone
Time frame: 03 days. Blood samples will be collected on Day 13 (pre-dose), Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hrs post-dose) and Day 15 (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hrs post dose).
Repeat doses PK of Darapladib assessed by Tmax, and T1/2 (as data permit) when co-administered with Rosuvastatin and when administered alone
Time frame: 03 days. Blood samples will be collected on Day 13 (pre-dose), Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hrs post-dose) and Day 15 (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hrs post dose).
Safety and tolerability of darapladib when co-administered with Rosuvastatin assessed by incidence and severity of adverse events
Time frame: Up to 60 days
Safety and tolerability of darapladib when co-administered with Rosuvastatin assessed by vital signs
Time frame: Up to 60 days
Safety and tolerability of darapladib when co-administered with Rosuvastatin assessed by clinical laboratory data
Time frame: Up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Results for study 115677 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosuvastatin 10 mg and Darapladib 160 mg in people with Atherosclerosis, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single dose PK of Rosuvastatin assessed by AUC (0-infinity) or AUC (0-t) when co-administered with darapladib and when administered alone. (time frame: 09 days. Blood samples will be collected on Day 1 to 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 hours [hrs] post dose) and on Day 15 to 18 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24, 36, 48, 72, and 96 hrs post dose).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.