A Phase 0, Open-label Study to Evaluate the Release and Absorption of the Polymer-bound Form of [14C]-PL8177 in the Distal Gastrointestinal Tract Following a Single Oral Dose in Healthy Male Subjects

A Phase 0, Open-label Study to Evaluate the Release and Absorption of the Polymer-bound Form of [14C]-PL8177 in the Distal Gastrointestinal Tract Following a Single Oral Dose in Healthy Male Subjects - PL8177 Microtracer study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46068

Enrollment

Registered

2018-08-29

Start date

2018-09-20

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis Ulcerosa Inflammatory Bowel

Interventions

The subject will receive a single dose of 70 microgram (µg)/33.3 kBq radiolabeled PL8177 as an oral capsule with 240 milliliters (mL) of (tap) water on Day 1. In addition to the study compound, volu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Males of any race, between 18 and 55 years of age, inclusive, at screening. ;2.Body mass index between 18.0 and 30.0 kg/m2, inclusive, at screening.;3.In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert*s syndrome] is not acceptable) at screening or admission (Day -1) as assessed by the Investigator (or designee).;4.Blood pressure at screening must be within the following ranges (measured with subjects in the supine position after they have rested for at least 5 minutes): systolic blood pressure >=90 and =45 and

Exclusion criteria

Exclusion criteria: 1. Employee of PRA or the Sponsor. 2. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). 3. History of irritable bowel syndrome, Crohn*s disease, or ulcerative colitis. 4. History of chronic constipation.

Design outcomes

Primary

Measure	Time frame
To demonstrate release of [14C]-PL8177 from the polymer-bound form of [14C] PL8177 in the colon after oral administration. This will be accomplished by observation of the formation of metabolite PL8435. To confirm that the orally administered, polymer-bound form of [14C] PL8177 does not result in systemic exposure to [14C]-PL8177 and/or metabolite [14C]-PL8435 (in healthy male subjects). To establish the relationship between an oral dose of polymer-bound [14C] PL8177 and the amount of [14C] PL8177 and/or metabolite [14C]-PL8435 in the colon.	—

Measure

Time frame

To demonstrate release of [14C]-PL8177 from the polymer-bound form of [14C] PL8177 in the colon after oral administration. This will be accomplished by observation of the formation of metabolite PL8435. To confirm that the orally administered, polymer-bound form of [14C] PL8177 does not result in systemic exposure to [14C]-PL8177 and/or metabolite [14C]-PL8435 (in healthy male subjects). To establish the relationship between an oral dose of polymer-bound [14C] PL8177 and the amount of [14C] PL8177 and/or metabolite [14C]-PL8435 in the colon.

—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of the orally administered, polymer-bound form of [14C] PL8177 in healthy male subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)