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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06309394
• Other study ID #: INCB99280-102
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2024
• Est. completion date: June 4, 2024

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 4, 2024
• Est. primary completion date: June 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Ltd	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total recovery of radioactivity from urine and feces.	To determine the route of elimination and mass balance of [14C]INCB099280 following administration of a single oral dose of INCB099280 followed by an oral dose solution of radio labeled INCB099280.	Approximately 2 months
Primary	Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion	To characterize the metabolic profile and identify circulating and excreted metabolites of INCB099280 following administration of a single oral dose of INCB099280 followed an oral dose solution of radio labeled INCB099280 using liquid chromatography with mass spectral detection.	Approximately 2 months
Secondary	Pharmacokinetic (PK) in Plasma	INCB099280 concentration in plasma.	Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5, post dose Day 6
Secondary	PK for whole blood and plasma total radioactivity	INCB099280 concentration for whole blood and plasma total radioactivity.	Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5, 6 and Days 7-12 as needed until study discharge
Secondary	Number of participants with Treatment Emergent Adverse Events (TEAEs)	Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.	Approximately 2 months