To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy Volunteers
A Phase 1, Single-center, Randomized, 2-Way Cross-over, Open-label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Cefadroxil in Healthy Volunteers
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Sequence 1 (Treatment A/B)
Subjects will be randomised to receive Treatment A in Period 1 followed by Treatment B in period 2
|
A single 500 mg oral dose of cefadroxil will be given on the morning of Day 1
15mg oral dose of AZD1722 will be given twice daily from Day 1 to Day 4 followed on the morning of Day 5 by a single dose of 15 mg AZD1722 taken together with a single 500mg dose of cefadroxil
|
|
Experimental: Sequence 2 (Treatment B/A)
Subjects will be randomised to receive Treatment B in Period 1 followed by Treatment A in period 2
|
A single 500 mg oral dose of cefadroxil will be given on the morning of Day 1
15mg oral dose of AZD1722 will be given twice daily from Day 1 to Day 4 followed on the morning of Day 5 by a single dose of 15 mg AZD1722 taken together with a single 500mg dose of cefadroxil
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the pharmacokinetics of cefadroxil when administered after AZD1722 by assessment of area under the concentration-time curve (AUC) and maximal plasma concentration (Cmax) of cefadroxil
Time Frame: Blood sampling for cefadroxil: Predose, 0.5 hour, 1, 1.5, 2, 2.5, 4, 6, 8, 10, and 12 hours postdose on Day 1 in Treatment A and on Day 5 in Treatment B
|
Change in plasma area under the concentration-time curve (AUC) and maximal plasma concentration (Cmax) of cefadroxil after AZD1722 administration.
|
Blood sampling for cefadroxil: Predose, 0.5 hour, 1, 1.5, 2, 2.5, 4, 6, 8, 10, and 12 hours postdose on Day 1 in Treatment A and on Day 5 in Treatment B
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the plasma concentrations of AZD1722
Time Frame: Blood sampling for AZD1722: Predose, 1, 2, and 4 hours postdose, on Day 5 (Treatment B)
|
To evaluate plasma concentrations of AZD1722 to be measured (no PK parameters derived)
|
Blood sampling for AZD1722: Predose, 1, 2, and 4 hours postdose, on Day 5 (Treatment B)
|
|
To evaluate the pharmacodynamic outcomes of AZD1722 by the assessment of how AZD1722 effects stool consistency and frequency
Time Frame: Stool frequency and stool consistency will be measured daily (24-hour period intervals) on Day -1 through Day 1 (Treatment A) and Day 1 through Day 5 (Treatment B)
|
Pharmacodynamic outcome of the effect on stool consistency and frequency
|
Stool frequency and stool consistency will be measured daily (24-hour period intervals) on Day -1 through Day 1 (Treatment A) and Day 1 through Day 5 (Treatment B)
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the safety profile when cefadroxil is administered after AZD1722 in terms of adverse events, vital signs, electrocardiogram, hematology, clinical chemistry, urinalysis and physical examination
Time Frame: Safety assessments performed through the screening period (Day -28) to 10 days after the last dose in Period 2
|
Description of the safety profile in terms of adverse events, vital signs, electrocardiogram, hematology, clinical chemistry, urinalysis and physical examination.
|
Safety assessments performed through the screening period (Day -28) to 10 days after the last dose in Period 2
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Eleanor - Lisbon, MD, Quintiles, Overland Park, Kansas
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- D5613C00004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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