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Safety, Tolerability, and Pharmacodynamics of RDX5791 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02796131
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Ardelyx

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: RDX5791 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Study Start Date : July 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: 30 mg bid
30 mg of RDX5791 administered twice daily PO (60 mg total dose/day).
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722

Drug: Placebo
Placebo

Experimental: 30 mg tid
30 mg of RDX5791 administered three times daily PO (90 mg total dose/day).
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722

Drug: Placebo
Placebo

Experimental: 60 mg bid
60 mg of RDX5791 administered two times daily (120 mg total dose/day).
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722

Drug: Placebo
Placebo

Experimental: 15 mg bid
15 mg of RDX5791 administered two times daily (30 mg total dose/day).
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722

Drug: Placebo
Placebo

Experimental: 30 mg QD
30 mg of RDX5791 administered once daily (30 mg total dose/day).
Drug: RDX5791
Other Names:
  • Tenapanor
  • AZD1722

Drug: Placebo
Placebo

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: RDX5791
Other Names:
  • Tenapanor
  • AZD1722

Drug: Placebo
Placebo

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: RDX5791
Other Names:
  • Tenapanor
  • AZD1722

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796131


Sponsors and Collaborators
Ardelyx
Investigators
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Study Chair: David P. Rosenbaum, Ph.D Ardelyx, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT02796131     History of Changes
Other Study ID Numbers: RDX5791-102
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016

Keywords provided by Ardelyx:
Phase I
Healthy
Pharmacodynamics

Additional relevant MeSH terms:
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Psyllium
Cathartics
Gastrointestinal Agents