A Phase 1 interventional study of RDX5791 and Placebo in Healthy, sponsored by Ardelyx. Completed. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-30.
Sponsored by Ardelyx · Phase 1, Interventional, and Basic science
A Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-and multiple-ascending doses of RDX5791 in healthy male and female subjects.
In the single-ascending dose (SAD), 5 separate cohorts received RDX5791 at various doses once po fasting. Each cohort of 8 subjects (6 RDX5791, 2 placebo) received a diet standardized fro Na+ content wile in the clinical pharmacology unit (CPU).
The PK data from the 50-mg dose and the safety data from the 150-mg dose of the SAD study were evaluated prior to proceeding with the multiple-ascending dose (MAD) phase. Doses of RDX5791 are 3, 10, 30, and 100 mg administered once daily po fasting. Four cohorts of 10 subjects each (8 RDX5791, 2 placebo) received a diet standardized for Na+ content while in the CPU.
Safety assessments including clinical assessment and vital signs, clinical laboratory evaluations, ECGs, and AE monitoring were performed at regular intervals. Plasma was collected at regular intervals for PK analysis. The PD assessment included stool frequency and consistency, as well as changes in urinary Na+ excretion. All bowel movements were collected and analyzed for Na+ content outside this study protocol.
Ardelyx is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
10mg of RDX5791 administered once daily PO fasting
Drug: RDX5791 · Drug: Placebo
50mg of RDX5791 administered once daily PO fasting
Drug: RDX5791 · Drug: Placebo
150mg of RDX5791 administered once daily PO fasting
Drug: RDX5791 · Drug: Placebo
450mg of RDX5791 administered once daily PO fasting
Drug: RDX5791 · Drug: Placebo
900mg of RDX5791 administered once daily PO fasting
Drug: RDX5791 · Drug: Placebo
3mg of RDX5791 administered once daily PO fasting
Drug: RDX5791 · Drug: Placebo
10mg of RDX5791 administered once daily PO fasting
Drug: RDX5791 · Drug: Placebo
30mg of RDX5791 administered once daily PO fasting
Drug: RDX5791 · Drug: Placebo
100mg of RDX5791 administered once daily PO fasting
Drug: RDX5791 · Drug: Placebo
Also known as: Tenapanor, AZD1722
Adverse events
serum chemistry and hematology, ECGs, and clinical signs and symptoms
Time frame: 7 days
Pharmacokinetics of RDX5791
blood levels of drug
Time frame: 7 days
Urinary and fecal sodium levels
to assess the pharmacodynamics of RDX5791
Time frame: 7 days
Urinary and fecal phosphorus levels
to assess the pharmacodynamics of RDX5791
Time frame: 7 days
No study locations are listed for this record.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenapanor