HealthyPhase 1NCT02796131
Safety, Tolerability, and Pharmacodynamics of RDX5791 in Healthy Volunteers
A Phase 1 study testing RDX5791 in people with Healthy, run by Ardelyx.
Trial summary
A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RDX5791
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Apr 2012
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 18 and 29.9 kg/m², inclusive
- No clinically significant abnormalities in medical history
- Females must be non-pregnant, non-lactating, and either postmenopausal for at least 12 months or have agreed to use an effective form of contraception from the time of signing the informed consent until 45 days after end of study
- Men must be either sterile, abstinent, or agreed to use an approved method of contraception from check-in until 45 days after final study visit
Who cannot join
- Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
- Any surgery on the small intestine or colon, excluding appendectomy
- Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days
- Hepatic dysfunction ([ALT] or [AST]) >1.5 times the upper limit of normal or renal impairment
- Any evidence of or treatment of malignancy, excluding non-melanomatous malignancies of the skin
- Use of diuretic medications, medications that are known to affect stool consistency and/or GI motility
Show all 10Show fewer
- Use of an investigational agent within 30 days prior to Day -2
- Positive virology, alcohol, or drugs of abuse test during screening
- Use of any prescription medication within 7 days before admission to the CPU
- Have had significant blood loss (>450 mL) or have donated 1 or more units of blood or plasma within 8 weeks prior to study entry
About this study
Official title: A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Different Multiple Dose Regimens of RDX5791 in Healthy Volunteers
A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in healthy volunteers.
Read the detailed description
The starting doses for this study are based on the results from the multiple ascending-dose study performed on RDX5791 (Protocol RDX5791-101). Subjects will be screened within 3 weeks of check in to the CPU. Each cohort of 15 subjects (12 RDX5791, 3 placebo) will check in to the CPU on Day -5 before dinner. Each subject will receive a diet standardized for Na+ content while in the CPU. Subjects will receive doses of RDX5791 with approximately 240 mL of non-carbonated water on Days 1 to 7 (just prior to meals, depending on QD, bid, or tid regimens). Subjects will be provided standardized meals within 10 minutes after dosing. Doses can be administered with breakfast, lunch, or dinner.
- Conditions
- Healthy
- Being tested
- RDX5791, Placebo
- Keywords
- Phase I, Healthy, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDX5791Drug
Also called Tenapanor, AZD1722
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 30 mg bid | Experimental | 30 mg of RDX5791 administered twice daily PO (60 mg total dose/day). Receives: Drug: RDX5791; Drug: Placebo |
| 30 mg tid | Experimental | 30 mg of RDX5791 administered three times daily PO (90 mg total dose/day). Receives: Drug: RDX5791; Drug: Placebo |
| 60 mg bid | Experimental | 60 mg of RDX5791 administered two times daily (120 mg total dose/day). Receives: Drug: RDX5791; Drug: Placebo |
| 15 mg bid | Experimental | 15 mg of RDX5791 administered two times daily (30 mg total dose/day). Receives: Drug: RDX5791; Drug: Placebo |
| 30 mg QD | Experimental | 30 mg of RDX5791 administered once daily (30 mg total dose/day). Receives: Drug: RDX5791; Drug: Placebo |
| Escalating dose bid | Experimental | 15 mg or 30 mg or 45 mg of RDX5791 administered two times daily (30, 60, or 90 mg total dose/day respectively). The stopping criteria for the dose escalation is based on Bristol Stool Score and AEs. Receives: Drug: RDX5791; Drug: Placebo |
| 30 mg bid with psyllium | Experimental | 30 mg of RDX5791 administered two times daily (60 mg total dose/day) with psyllium taken up to three times per day (maximum of 15 g psyllium/day). Receives: Drug: RDX5791; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of different dosing regimens of RDX5791
Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams.
Measured: 7 Days
Secondary outcomes (1)
Pharmacodynamics of different dosing regimens of RDX5791
Pharmacodynamics of different dosing regimens of RDX5791 will be assessed by bowel movement timing, consistency, frequency, and by urine and stool sodium (Na+) excretion.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David P. Rosenbaum, Ph.D, Study chair, Ardelyx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796131
- Sponsor's protocol ID
- RDX5791-102
- Status last verified
- Jun 2016
- First submitted
- 7 Jun 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenbaum DP, Yan A, Jacobs JW. Pharmacodynamics, Safety, and Tolerability of the NHE3 Inhibitor Tenapanor: Two Trials in Healthy Volunteers. Clin Drug Investig. 2018 Apr;38(4):341-351. doi: 10.1007/s40261-017-0614-0.
PubMed 29363027
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Different Multiple Dose Regimens of RDX5791 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02796131
- Acronym / sponsor ID
- RDX5791-102
- Conditions
- Healthy
- Keywords
- Phase I, Healthy, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Jun 2016 (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 Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in healthy volunteers.
Detailed description
The starting doses for this study are based on the results from the multiple ascending-dose study performed on RDX5791 (Protocol RDX5791-101). Subjects will be screened within 3 weeks of check in to the CPU. Each cohort of 15 subjects (12 RDX5791, 3 placebo) will check in to the CPU on Day -5 before dinner. Each subject will receive a diet standardized for Na+ content while in the CPU. Subjects will receive doses of RDX5791 with approximately 240 mL of non-carbonated water on Days 1 to 7 (just prior to meals, depending on QD, bid, or tid regimens). Subjects will be provided standardized meals within 10 minutes after dosing. Doses can be administered with breakfast, lunch, or dinner.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 30 mg bid | Experimental | Drug: RDX5791, Drug: Placebo30 mg of RDX5791 administered twice daily PO (60 mg total dose/day). |
| 30 mg tid | Experimental | Drug: RDX5791, Drug: Placebo30 mg of RDX5791 administered three times daily PO (90 mg total dose/day). |
| 60 mg bid | Experimental | Drug: RDX5791, Drug: Placebo60 mg of RDX5791 administered two times daily (120 mg total dose/day). |
| 15 mg bid | Experimental | Drug: RDX5791, Drug: Placebo15 mg of RDX5791 administered two times daily (30 mg total dose/day). |
| 30 mg QD | Experimental | Drug: RDX5791, Drug: Placebo30 mg of RDX5791 administered once daily (30 mg total dose/day). |
| Escalating dose bid | Experimental | Drug: RDX5791, Drug: Placebo15 mg or 30 mg or 45 mg of RDX5791 administered two times daily (30, 60, or 90 mg total dose/day respectively). The stopping criteria for the dose escalation is based on Bristol Stool Score and AEs. |
| 30 mg bid with psyllium | Experimental | Drug: RDX5791, Drug: Placebo30 mg of RDX5791 administered two times daily (60 mg total dose/day) with psyllium taken up to three times per day (maximum of 15 g psyllium/day). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index between 18 and 29.9 kg/m², inclusive
- No clinically significant abnormalities in medical history
- Females must be non-pregnant, non-lactating, and either postmenopausal for at least 12 months or have agreed to use an effective form of contraception from the time of signing the informed consent until 45 days after end of study
- Men must be either sterile, abstinent, or agreed to use an approved method of contraception from check-in until 45 days after final study visit
Key exclusion criteria (10 listed)
- Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
- Any surgery on the small intestine or colon, excluding appendectomy
- Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days
- Hepatic dysfunction ([ALT] or [AST]) >1.5 times the upper limit of normal or renal impairment
- Any evidence of or treatment of malignancy, excluding non-melanomatous malignancies of the skin
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 |
|---|---|---|
| RDX5791Also: Tenapanor, AZD1722 | Drug | 15 mg bid, 30 mg QD, 30 mg bid, 30 mg bid with psyllium, 30 mg tid, 60 mg bid, Escalating dose bid |
| PlaceboPlacebo | Drug | 15 mg bid, 30 mg QD, 30 mg bid, 30 mg bid with psyllium, 30 mg tid, 60 mg bid, Escalating dose bid |
Primary outcome
Safety of different dosing regimens of RDX5791
Time frame: 7 Days
Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams.
1 secondary outcome
Pharmacodynamics of different dosing regimens of RDX5791
Time frame: 7 Days
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 10 Jun 2016.
- Derived from this study: PubMed 29363027Rosenbaum DP, Yan A, Jacobs JW. Pharmacodynamics, Safety, and Tolerability of the NHE3 Inhibitor Tenapanor: Two Trials in Healthy Volunteers. Clin Drug Investig. 2018 Apr;38(4):341-351. doi: 10.1007/s40261-017-0614-0.
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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.
David P. Rosenbaum, Ph.D study chair
Ardelyx, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RDX5791 in people with Healthy, run by Ardelyx.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. 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 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety of different dosing regimens of RDX5791 (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796131, which also lists 1 linked publication.
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 10 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.