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.
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.
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
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| Sequence 1 (Treatment A/B) | Experimental | Subjects 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) | Experimental | Subjects 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.
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)
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)
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.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eleanor - Lisbon, MD, Principal investigator, Quintiles, Overland Park, Kansas
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02140281
- Acronym / sponsor ID
- D5613C00004
- Conditions
- Healthy Volunteers
- Keywords
- Phase I, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 May 2014 (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.
A study to evaluate the effect of repeated oral doses of AZD1722 on the pharmacokinetics of Cefadroxil
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (Treatment A/B) | Experimental | Drug: Treatment A (cefadroxil alone), Drug: Treatment B - AZD1722 followed by cefadroxilSubjects will be randomised to receive Treatment A in Period 1 followed by Treatment B in period 2 |
| Sequence 2 (Treatment B/A) | Experimental | Drug: Treatment A (cefadroxil alone), Drug: Treatment B - AZD1722 followed by cefadroxilSubjects will be randomised to receive Treatment B in Period 1 followed by Treatment A in period 2 |
Who may qualify
- Ages
- 18 days to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Treatment A (cefadroxil alone)A single 500 mg oral dose of cefadroxil will be given on the morning of Day 1 | Drug | Sequence 1 (Treatment A/B), Sequence 2 (Treatment B/A) |
| Treatment B - AZD1722 followed by cefadroxil15mg 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 | Drug | Sequence 1 (Treatment A/B), Sequence 2 (Treatment B/A) |
Primary outcome
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.
2 secondary outcomes
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 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)
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 22 Sep 2015.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Eleanor - Lisbon, MD principal investigator
Quintiles, Overland Park, Kansas
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 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.