Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib (Statin DDI)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01725230
First received: November 7, 2012
Last updated: February 1, 2013
Last verified: January 2013
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Purpose
A study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin when administered alone or in combination with Fostamatinib.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Fostamatinib Drug: Rosuvastatin Drug: Simvastatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Pharmacokinetics of Rosuvastatin measured by AUC and Cmax. [ Time Frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose. ] [ Designated as safety issue: No ]
- Pharmacokinetics of Simvastatin measured by AUC and Cmax [ Time Frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetics of R406 measured by AUC(0-t), Cmax, Tmax (alone and in combination with rosuvastatin or simvastatin) [ Time Frame: Day 1 to day 4 at predose, Day 5 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours postdose. ] [ Designated as safety issue: No ]
- Pharmacokinetics of rosuvastatin measured by AUC(0-t), t1/2, Tmax, Cl/F and Vz/F (alone and in combination with fostamatinib) [ Time Frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose. ] [ Designated as safety issue: No ]
- Pharmacokinetics of Simvastatin measured by AUC(0-t)m t1/2, and Tmax (alone and in combination with fostamatinib) [ Time Frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose. ] [ Designated as safety issue: No ]
- Pharmacokinetics of simvastatin measured by AUC, Cmax, AUC(0-t), t1/2, Tmax, C1/F and Vz/F (alone and in combination with fostamatinib) [ Time Frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose. ] [ Designated as safety issue: No ]
- Frequency of adverse events [ Time Frame: Measured throughout the study and 3-5 days after discharge from Period 2, approximately 72 days ] [ Designated as safety issue: Yes ]
- Severity of adverse events [ Time Frame: Measured throughout the study and 3-5 days after discharge from Period 2, approximately 72 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 42 |
| Study Start Date: | November 2012 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rosuvastatin
Single, oral dose of rosuvastatin 20mg in first period and in second period (after wash out) fostamatinib 100 mg twice daily, then single oral dose of rosuvastatin 20 mg plus continued oral dosing of fostamatinib 100 mg twice daily, then continue fostamatinib 100 mg twice daily
|
Drug: Fostamatinib
100-mg tablet
Drug: Rosuvastatin
20-mg tablet
|
|
Experimental: Simvastatin
Single, oral dose of simvastatin 40 mg in first period and in second period (after wash out) fostamatinib 100 mg twice daily, then single oral dose of simvastatin 40 mg plus continued oral dosing of fostamatinib 100 mg twice daily, then continue fostamatinib 100 mg twice daily
|
Drug: Fostamatinib
100-mg tablet
Drug: Simvastatin
40-mg tablet
|
Detailed Description:
An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects when Administered Alone and in Combination with Fostamatinib 100 mg Twice Daily.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Provision of signed and dated, written informed consent, prior to any study-specific procedures
- Volunteers will be males or females aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2, inclusive.
- Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of first dosing until 2 weeks after the last dosing with IP.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non childbearing potential, confirmed at screening .
Exclusion Criteria:
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP as judged by the Investigator.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
- Any clinically significant abnormal findings in vital signs as judged by the Investigator
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725230
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725230
Locations
| United States, Kansas | |
| Research Site | |
| Overland Park, Kansas, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | David Mathews, MD | Quintiles Phase I unit 6700 w 115th st Overland Park, Ks 66211 |
| Study Director: | Christopher D O'Brien, MD PHD | AstraZeneca |
More Information
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01725230 History of Changes |
| Other Study ID Numbers: | D4300C00039 |
| Study First Received: | November 7, 2012 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Fostamatinib, simvastatin, rosuvastatin, |
Phase I, Healthy Subjects, Pharmacokinetics |
Additional relevant MeSH terms:
|
Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Simvastatin |
Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016