A Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects

NCT05042986 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: OCSO-P1204
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a Phase I, open-label, nonrandomized, single dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8. On the morning of Day 1, all subjects will receive a single oral dose of \[14C\]-SKI-O-703. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥ 90% mass balance recovery, and ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site up to Day 15.

Conditions

Healthy Volunteers

Keywords

Healthy Male Subjects

Outcome Measures

Primary Outcomes (18)

• AUC (Area under creative curve) from time zero to infinity (AUC0-∞)

  Baseline through day 43

• AUC from time zero to the last quantifiable concentration (AUC0-tlast)

  Baseline through day 43

• Time to Cmax

  Baseline through day 43

• Time to tmax

  Baseline through day 43

• Time to t1/2

  Baseline through day 43

• Apparent total clearance (CL/F; plasma SKI-O-592 only)

  Baseline through day 43

• Apparent volume of distribution (Vz/F; plasma SKI-O-592 only)

  Baseline through day 43

• AUC0-∞ of plasma SKI-O-592 relative to AUC0-∞ of plasma total radioactivity (AUC0-∞ Plasma SKI-O-592/Total Radioactivity Ratio)

  Baseline through day 43

• AUC0-∞ of whole blood total radioactivity to AUC0-∞ of plasma total radioactivity (AUC0-∞ Blood/Plasma Ratio

  Baseline through day 43

• Amount of SKI-O-592 and total radioactivity excreted in urine (Aeu)

  Baseline through day 43

• Cumulative Aeu of SKI-O-592 and total radioactivity

  Baseline through day 43

• Percentage of SKI-O-592 excreted in urine (feu) and total radioactivity

  Baseline through day 43

• Cumulative feu of SKI-O-592 and total radioactivity

  Baseline through day 43

• Renal clearance (CLR; SKI-O-592 only)

  Baseline through day 43

• Amount of total radioactivity excreted in feces (Aef)

  Baseline through day 43

• Cumulative radioactivity Aef

  Baseline through day 43

• Percentage of total radioactivity excreted in feces (fef)

  Baseline through day 43

• Cumulative radioactivity fef

  Baseline through day 43

Secondary Outcomes (7)

• Metabolic profile of SKI-O-592

  Baseline through day 43

• Identifications of SKI-O-592 metabolites

  Baseline through day 43

• Number and severity of AEs

  Screening through day 43

• incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

  Screening through day 43

• Incidence of abnormal 12-Lead ECG

  Screening through day 43

Study Arms (1)

Single Dose Capsule

EXPERIMENTAL

Single oral dose of 200 mg (100 μCi in 200 mg salt \[0.5 μCi/mg as salt\], equivalent to 100 μCi in 142 mg active \[0.7 μCi/mg as active\]) of \[14C\]-SKI-O-703 containing approximately 100 μCi of \[14C\]-SKI-O-703 per capsule after an overnight fast.

Drug: .[14C]-SKI-O-703

Interventions

.[14C]-SKI-O-703 DRUG

Single oral dose of 200 mg (100 μCi in 200 mg salt \[0.5 μCi/mg as salt\], equivalent to 100 μCi in 142 mg active \[0.7 μCi/mg as active\]) of \[14C\]-SKI-O-703 containing approximately 100 μCi of \[14C\]-SKI-O-703 per capsule after an overnight fast.

Single Dose Capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males, of any race, between 18 and 55 years of age, inclusive.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and/or check-in as assessed by the investigator (or designee).
• Subjects will agree to use contraception as detailed in the protocol
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
• History of a minimum of 1 bowel movement per day.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy is not allowed.
• History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
• Alcohol consumption of \> 21 units per week. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
• Positive urine drug screen at screening or positive alcohol urine test result or positive urine drug screen at check-in.
• Positive hepatitis panel and/or positive human immunodeficiency virus test (Appendix 2).
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 5 half-lives of the drug, if known, or 30 days, whichever is longer, prior to last dose of the previous study.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, cytochrome P450 1A2 and UGT1A1 inhibitors/inducers, or elimination processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in.
• Receipt of blood products within 2 months prior to check-in.
• Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.

Sponsors & Collaborators

• Oscotec Inc.: lead

Study Sites (1)

Labcorp Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Study Chair

  Oscotec Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: August 10, 2021
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)