PK and Safety of SI-722 in IC/BPS

This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.

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Key information

Conditions

Interstitial Cystitis Bladder Pain Syndrome Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

American Institute of Research, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males or females, ≥18 and ≤80 years of age
A score of 19 or greater on the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)

Exclusion criteria

Urinary tract infection ≤30 days
Treatment with intravesical therapy ≤60 days
Treatment with any opioid therapy ≤7 days
History of bladder hydrodistension ≤3 months
Has cancer or a past history of any cancer ≤5 years
Body mass index (BMI) ≥40 kg/m2

Treatment and study plan

SI-722

Drug

SI-722 will be intravesically instilled.

Placebo

Drug

Placebo will be intravesically instilled.

Primary outcomes

Maximum Plasma Concentration (Cmax) for SI-722

Time frame: 4 weeks

SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated.

Sponsors and collaborators

Lead sponsor

Seikagaku Corporation

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of SI-722 Intravesical Instillation in Interstitial Cystitis/Bladder Pain Syndrome Subjects

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Dec 23, 2019
Registry last updated: Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed