Safety, Tolerability, and Pharmacodynamics of RDX5791 in Healthy Volunteers

NCT02796131 | Completed Phase 1

• 1 other identifier: RDX5791-102
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Phase I; Healthy; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Safety of different dosing regimens of RDX5791

  Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams.

  7 Days

Secondary Outcomes (1)

• Pharmacodynamics of different dosing regimens of RDX5791

  7 Days

Study Arms (7)

30 mg bid

EXPERIMENTAL

30 mg of RDX5791 administered twice daily PO (60 mg total dose/day).

Drug: RDX5791; Drug: Placebo

30 mg tid

EXPERIMENTAL

30 mg of RDX5791 administered three times daily PO (90 mg total dose/day).

Drug: RDX5791; Drug: Placebo

60 mg bid

EXPERIMENTAL

60 mg of RDX5791 administered two times daily (120 mg total dose/day).

Drug: RDX5791; Drug: Placebo

15 mg bid

EXPERIMENTAL

15 mg of RDX5791 administered two times daily (30 mg total dose/day).

Drug: RDX5791; Drug: Placebo

30 mg QD

EXPERIMENTAL

30 mg of RDX5791 administered once daily (30 mg total dose/day).

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.

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).

Drug: RDX5791; Drug: Placebo

Interventions

RDX5791 DRUG

Also known as: Tenapanor, AZD1722

15 mg bid; 30 mg QD; 30 mg bid; 30 mg bid with psyllium; 30 mg tid; 60 mg bid; Escalating dose bid

Placebo DRUG

Placebo

15 mg bid; 30 mg QD; 30 mg bid; 30 mg bid with psyllium; 30 mg tid; 60 mg bid; Escalating dose bid

Eligibility Criteria

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

You may qualify if:

• 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

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: 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 10, 2016
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2012
• Last Updated: June 10, 2016

Record last verified: 2016-06