Safety, Tolerability, and Pharmacodynamics of RDX5791 in Healthy Volunteers

June 7, 2016 updated by: Ardelyx

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 30 mg bid
30 mg of RDX5791 administered twice daily PO (60 mg total dose/day).
Drug: Placebo
Placebo
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722
EXPERIMENTAL: 30 mg tid
30 mg of RDX5791 administered three times daily PO (90 mg total dose/day).
Drug: Placebo
Placebo
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722
EXPERIMENTAL: 60 mg bid
60 mg of RDX5791 administered two times daily (120 mg total dose/day).
Drug: Placebo
Placebo
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722
EXPERIMENTAL: 15 mg bid
15 mg of RDX5791 administered two times daily (30 mg total dose/day).
Drug: Placebo
Placebo
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722
EXPERIMENTAL: 30 mg QD
30 mg of RDX5791 administered once daily (30 mg total dose/day).
Drug: Placebo
Placebo
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722
EXPERIMENTAL: Escalating dose bid
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.
Drug: Placebo
Placebo
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722
EXPERIMENTAL: 30 mg bid with psyllium
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).
Drug: Placebo
Placebo
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacodynamics of different dosing regimens of RDX5791
Time Frame: 7 Days
Pharmacodynamics of different dosing regimens of RDX5791 will be assessed by bowel movement timing, consistency, frequency, and by urine and stool sodium (Na+) excretion.
7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ardelyx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RDX5791-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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