Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RDX5791 in Healthy Volunteers

NCT02819687 | Completed Phase 1

• 1 other identifier: RDX5791-101
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

Phase I; Healthy; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Adverse events

  serum chemistry and hematology, ECGs, and clinical signs and symptoms

  7 days

Secondary Outcomes (3)

• Pharmacokinetics of RDX5791

  7 days

• Urinary and fecal sodium levels

  7 days

• Urinary and fecal phosphorus levels

  7 days

Study Arms (9)

RDX5791 10mg QD (SAD phase)

EXPERIMENTAL

10mg of RDX5791 administered once daily PO fasting

Drug: RDX5791; Drug: Placebo

RDX5791 50mg QD (SAD phase)

EXPERIMENTAL

50mg of RDX5791 administered once daily PO fasting

Drug: RDX5791; Drug: Placebo

RDX5791 150mg QD (SAD phase)

EXPERIMENTAL

150mg of RDX5791 administered once daily PO fasting

Drug: RDX5791; Drug: Placebo

RDX5791 450mg QD (SAD phase)

EXPERIMENTAL

450mg of RDX5791 administered once daily PO fasting

Drug: RDX5791; Drug: Placebo

RDX5791 900mg QD (SAD phase)

EXPERIMENTAL

900mg of RDX5791 administered once daily PO fasting

Drug: RDX5791; Drug: Placebo

RDX5791 3mg QD (MAD phase)

EXPERIMENTAL

3mg of RDX5791 administered once daily PO fasting

Drug: RDX5791; Drug: Placebo

RDX5791 10mg QD (MAD phase)

EXPERIMENTAL

10mg of RDX5791 administered once daily PO fasting

Drug: RDX5791; Drug: Placebo

RDX5791 30 mg QD (MAD phase)

EXPERIMENTAL

30mg of RDX5791 administered once daily PO fasting

Drug: RDX5791; Drug: Placebo

RDX5791 100 mg QD (MAD phase)

EXPERIMENTAL

100mg of RDX5791 administered once daily PO fasting

Drug: RDX5791; Drug: Placebo

Interventions

RDX5791 DRUG

Also known as: Tenapanor, AZD1722

RDX5791 100 mg QD (MAD phase); RDX5791 10mg QD (MAD phase); RDX5791 10mg QD (SAD phase); RDX5791 150mg QD (SAD phase); RDX5791 30 mg QD (MAD phase); RDX5791 3mg QD (MAD phase); RDX5791 450mg QD (SAD phase); RDX5791 50mg QD (SAD phase); RDX5791 900mg QD (SAD phase)

Placebo DRUG

RDX5791 100 mg QD (MAD phase); RDX5791 10mg QD (MAD phase); RDX5791 10mg QD (SAD phase); RDX5791 150mg QD (SAD phase); RDX5791 30 mg QD (MAD phase); RDX5791 3mg QD (MAD phase); RDX5791 450mg QD (SAD phase); RDX5791 50mg QD (SAD phase); RDX5791 900mg QD (SAD phase)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 18 and 29.9 kg/m², inclusive
• Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
• Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization

You may not qualify if:

• 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

Sponsors & Collaborators

• Ardelyx: lead

Related Publications (1)

• 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.

  PMID: 29363027 DERIVED

MeSH Terms

Interventions

tenapanor

Study Officials

• David P. Rosenbaum, Ph.D

  Ardelyx, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 30, 2016
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 30, 2016

Record last verified: 2016-06