NCT02140281 is a Phase 1 clinical trial of Treatment A (cefadroxil alone) in Healthy Volunteers, sponsored by Ardelyx.

Who is sponsoring NCT02140281?

NCT02140281 is sponsored by Ardelyx.

What drugs are being tested in NCT02140281?

Interventions in NCT02140281: Treatment A (cefadroxil alone), Treatment B - AZD1722 followed by cefadroxil.

What condition does NCT02140281 study?

NCT02140281 studies Healthy Volunteers.

Is NCT02140281 still recruiting?

NCT02140281 is currently completed. Last updated 18 September 2015.

Last reviewed 2015-09-18 · How we verify

NCT02140281

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 18 September 2015

What this trial tests

Phase 1 trial testing Treatment A (cefadroxil alone) in Healthy Volunteers in 71 participants. Completed in 1 August 2014.

Timeline

1 May 2014

Primary endpoint
1 August 2014

1 August 2014

Quick facts

Lead sponsor	Ardelyx
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	71
Start date	1 May 2014
Primary completion	1 August 2014
Estimated completion	1 August 2014
Sites	1 location across United States

Drugs / interventions tested

Treatment A (cefadroxil alone) — full drug profile →
Treatment B - AZD1722 followed by cefadroxil — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Ardelyx — full company profile →

Who can join

Adults 18 Days to 50, any sex, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Tenapanor administration and the activity of the H<sup>+</sup> -coupled transporter PepT1 in healthy volunteers.
Johansson S, Rosenbaum DP, Palm J, Stefansson B, et al · · 2017 · cited 8× · PMID 28432691 · DOI 10.1111/bcp.13313

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

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Other Ardelyx trials

Trials by the same sponsor.

NCT07382167 — A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults · Phase 3 · recruiting
NCT06203444 — An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females · Phase 1 · completed
NCT05643534 — Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years · Phase 3 · recruiting
NCT04780841 — A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia · Phase 2 · completed
NCT04549597 — Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02140281 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ardelyx
Last refreshed: 18 September 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02140281.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing