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Healthy VolunteersPhase 1NCT02140281

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

A Phase 1 study testing Treatment A (cefadroxil alone) and Treatment B - AZD1722 followed by cefadroxil in people with Healthy Volunteers, run by Ardelyx at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study to evaluate the effect of repeated oral doses of AZD1722 on the pharmacokinetics of Cefadroxil Read more about this study

Who is it for?
Ages 18 days to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Treatment A (cefadroxil alone) and Treatment B - AZD1722 followed by cefadroxil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteUnited States
Study dates
May 2014to Aug 2014
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 18 days to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Inclusion Criteria:- 1. Healthy male and female volunteers aged ≥18 years to ≤50 years (inclusive) with suitable veins for cannulation or repeated venepuncture 2. Females could be of non-childbearing potential and child bearing potential Females of non-child bearing potential should be Post-menopausal, documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. Females of childbearing potential must have a negative pregnancy test at screening and must not be lactating, using one of the following effective methods to avoid pregnancy during the treatment periods, must have an established use of oral, injected, or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system, use a barrier method of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal. Male healthy volunteers with a partner of childbearing potential must agree to avoid fathering a child, and refrain from donating sperm, from the first day of dosing until at least 3 months after last dose of investigational product, and therefore be either sterile (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) or agree to use, one of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner or use by female sexual partner of an acceptable form of effective contraception (see above) 3. Have a body mass index (BMI) ≥18 and ≤30 kg/m2 and weigh at least 50 kg and no more than 100 kg Exclusion Criteria: 1.History of any clinically significant disease or disorder which, in the opinion of the principal investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study. 2.History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs. 3.Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product. 3 History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the principal investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD1722 or cefadroxil. 4. Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 30 days of the first administration of investigational product in this study. 5. Loose stools for ≥2 days in the past 7 days before investigational product administration. Use of medications that are known to affect stool consistency and/or GI motility, including fibre supplements, anti diarrheals, prokinetic drugs, enemas, probiotic medications or supplements; or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before randomization

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Research Site

    Overland Park, Kansas

Other trials in United States

About this study

Official title: 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

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

Read the detailed description

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

Being tested
Treatment A (cefadroxil alone), Treatment B - AZD1722 followed by cefadroxil
Keywords
Phase I, Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment A (cefadroxil alone)Drug

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

  • Treatment B - AZD1722 followed by cefadroxilDrug

    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

Study groups in NCT02140281
Study groupRoleWhat they receive
Sequence 1 (Treatment A/B)ExperimentalSubjects will be randomised to receive Treatment A in Period 1 followed by Treatment B in period 2
Receives: Drug: Treatment A (cefadroxil alone); Drug: Treatment B - AZD1722 followed by cefadroxil
Sequence 2 (Treatment B/A)ExperimentalSubjects will be randomised to receive Treatment B in Period 1 followed by Treatment A in period 2
Receives: Drug: Treatment A (cefadroxil alone); Drug: Treatment B - AZD1722 followed by cefadroxil

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. To evaluate the plasma concentrations of AZD1722

    To evaluate plasma concentrations of AZD1722 to be measured (no PK parameters derived)

    Measured: Blood sampling for AZD1722: Predose, 1, 2, and 4 hours postdose, on Day 5 (Treatment B)

  2. To evaluate the pharmacodynamic outcomes of AZD1722 by the assessment of how AZD1722 effects stool consistency and frequency

    Pharmacodynamic outcome of the effect on stool consistency and frequency

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02140281
Sponsor's protocol ID
D5613C00004
Status last verified
Sep 2015
First submitted
14 May 2014
Last updated
22 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment A (cefadroxil alone) and Treatment B - AZD1722 followed by cefadroxil in people with Healthy Volunteers, run by Ardelyx 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?

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 22 Sep 2015. 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?

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). 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 22 Sep 2015.

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