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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ardelyx

Criteria

Inclusion Criteria:

• 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

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