Status:
COMPLETED
A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a first-in-human study to evaluate the safety and tolerability of single ascending doses of IW-3300. The study drug will be administered rectally as a low-volume (20 mL) enema. Study participa...
Detailed Description
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study assessing the safety, tolerability, and pharmacokinetics (PK) of IW 3300 administered rectal...
Eligibility Criteria
Inclusion
- Males and female subjects of non-childbearing potential
- Ages 18 to 60 years
- Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Normal bowel movement frequency of formed stool at baseline (≥3 per week and ≤3 per day; average Bristol stool form scale (BSFS) score of \>2 and \<6).
- Body mass index (BMI) within the range 18.5 to 35.0 kg/m2 (inclusive) at the Screening Visit.
- Male subjects and female partners are willing to use double-barrier method of contraception during the study.
- If subject is ≥45 years of age, subject is compliant with colorectal cancer screening guidelines according to the American College of Gastroenterology (ACG) Clinical Guidelines: Colorectal Cancer Screening 2021.
Exclusion
- Evidence or history of clinically significant acute or chronic disease, or clinically significant illness within 30 days of the Screening Visit.
- History of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
- History of any condition that would interfere with their ability to receive an enema, or has had difficulty receiving an enema in the past.
- Recent history of anal fissure, anal abscess, complicated hemorrhoids, or presence or history of inflammatory bowel disease.
- Used a prescription medication during the 14 days before Check-in
- Used any over-the-counter medications, including laxatives, and herbal supplements during the 7 days before Check-in.
- Received a licensed or investigational vaccine during the 30 days before Check-in or is planning to receive any vaccine during the study.
- Recently received or donated blood products.
- Undergone a surgical procedure during the 30 days before Check-in, other than minor dermatologic procedures, or has a history of surgery involving the GI tract or anal canal (with the exception of endoscopic procedures, appendectomy, and cholecystectomy).
- Received any investigational drug during the 30 days or 5 half-lives of that investigational drug (whichever is longer) before the Screening Visit, or is planning to receive another investigational drug at any time during the study.
- Abnormal laboratory tests or clinically significant findings on safety tests conducted at the Screening Visit or at Check-in.
- Confirmed or suspected infection with COVID-19 at the Screening Visit or Check-in.
- Positive serology for human immunodeficiency virus (HIV) 1, HIV 2, or hepatitis B surface antigen (HBsAg), or positive for anti-HIV 1, anti-HIV 2, or anti hepatitis C virus (HCV) antibodies at the Screening Visit.
- History of alcohol or drug addiction during the year before the Screening Visit, or has a positive drug or alcohol screen at the Screening Visit or Check-in.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05188261
Start Date
January 18 2022
End Date
March 21 2022
Last Update
December 8 2023
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78744