A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants

NCT06309394 | Completed Phase 1 Results

• 1 other identifier: INCB99280-102
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of \[14C\]INCB099280 in Healthy Male Participants.

Conditions

Healthy Participants

Keywords

INCB099280

Outcome Measures

Primary Outcomes (1)

• Total Recovery (Urine + Feces) of the Administered Radioactivity

  Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted.

  264 hours in urine; 408 hours in feces

Secondary Outcomes (24)

• Abundance of INCB099280 Detected in Plasma

  0 hours (predose) and up to 24 hours post-dose

• Abundance of INCB099280 Metabolites Detected in Feces

  0 hours (predose) and up to 96 hours post-dose

• Cmax of INCB099280

  0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

• Tmax of INCB099280

  0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

• AUC0-t of INCB099280

  0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Study Arms (1)

INCB099280

EXPERIMENTAL

Participants will be administered INCB099280 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280.

Drug: INCB099280

Interventions

INCB099280 DRUG

INCB099280 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280.

INCB099280

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to comprehend and willingness to sign a written ICF for the study.
• Healthy males, as determined by the investigator based upon physical examinations, ECGs, vital signs, and safety laboratory assessments, aged 35 to 55 years, inclusive, at the time of signing the ICF.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive, at the time of screening.
• No clinically significant findings in screening evaluations (eg, clinical, laboratory, vital signs, and ECG) at screening and Day -1.
• Ability to swallow and retain oral medication.

You may not qualify if:

• History of clinically significant respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease as judged by the investigator.
• History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure \> 140 mm Hg or diastolic blood pressure \> 90 mmHg at screening, confirmed by repeat testing).
• Presence of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could possibly affect drug absorption.
• Current or recent (within 6 months before screening), clinically significant, gastrointestinal disease or surgery (including cholecystectomy, excluding appendectomy) that could affect the absorption of study drug.
• Any major surgery within 6 months of screening.
• Donation of blood to a blood bank or in a clinical study (except a screening visit) within 3 months before screening (within 2 weeks for plasma donation).
• Positive test for HBV, HCV, or HIV at screening. Participants whose HBV results are compatible with prior immunization or immunity due to infection may be included at the discretion of the investigator.
• Regular alcohol consumption \> 21 units per week (1 unit = 8 oz of beer or a 25-mL shot of a 40% spirit; 1.5 to 2 units = a 125-mL glass of wine, depending on type).
• Positive breath test for alcohol or positive urine screen for drugs of abuse (confirmed by repeat) at screening or admission (Day -1).
• Treatment with another investigational medication within 90 days or 5 half-lives (whichever is longer) before Day 1 or current enrollment in another investigational drug study.
• Participation in any clinical study involving a 14C-radiolabeled investigational product within 12 months prior to admission (Day -1).
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
• History of tobacco- or nicotine-containing product use within 1 month before screening. Consumption of tobacco- or nicotine-containing products 72 hours before admission (Day -1) until CRU discharge is not permitted. Breath test for carbon monoxide \> 10 ppm (confirmed by repeat) at screening or admission (Day -1).
• Use of prescription drugs within 14 days before Day 1 or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) within 7 days before Day 1 until CRU discharge. However, paracetamol up to 4000 mg Q24H and ibuprofen up to 600 mg Q24H are permitted.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Quotient Sciences Ltd

Nottingham, NG11 6JS, United Kingdom

Location

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Incyte Medical

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 13, 2024
• Study Start: May 15, 2024
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)