To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy Volunteers

NCT02140281 | Completed Phase 1

• 1 other identifier: D5613C00004
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate the effect of repeated oral doses of AZD1722 on the pharmacokinetics of Cefadroxil

Conditions

Healthy Volunteers

Keywords

Phase I, Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (2)

• To evaluate the plasma concentrations of AZD1722

  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

  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 Outcomes (1)

• 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

  Safety assessments performed through the screening period (Day -28) to 10 days after the last dose in Period 2

Study Arms (2)

Sequence 1 (Treatment A/B)

EXPERIMENTAL

Subjects will be randomised to receive Treatment A in Period 1 followed by Treatment B in period 2

Drug: Treatment A (cefadroxil alone); Drug: Treatment B - AZD1722 followed by cefadroxil

Sequence 2 (Treatment B/A)

EXPERIMENTAL

Subjects will be randomised to receive Treatment B in Period 1 followed by Treatment A in period 2

Drug: Treatment A (cefadroxil alone); Drug: Treatment B - AZD1722 followed by cefadroxil

Interventions

Treatment A (cefadroxil alone) DRUG

A single 500 mg oral dose of cefadroxil will be given on the morning of Day 1

Sequence 1 (Treatment A/B); Sequence 2 (Treatment B/A)

Treatment B - AZD1722 followed by cefadroxil DRUG

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

Sequence 1 (Treatment A/B); Sequence 2 (Treatment B/A)

Eligibility Criteria

• Age: 18 Days - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

Cefadroxil

Intervention Hierarchy (Ancestors)

Cephalexin; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eleanor - Lisbon, MD

  Quintiles, Overland Park, Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

US (1)