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Not Yet Recruiting NCT07812077

A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954

Conditions: Healthy Participants

Sex: Male
Ages: 30 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 16
Sponsor: AstraZeneca

Summary

This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body. This two-part study will take place at one site in Nottingham, United Kingdom, and will enroll 8 healthy men in each part, aged 30-65 years.

Eligibility Criteria

Inclusion Criteria: * Healthy males aged 30 to 65 years inclusive * BMI of 18.0 to 35.0 kg/m2 inclusive * Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) Exclusion Criteria: * Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients * Presence or history of clinically significant allergy requiring treatment * History of clinically significant cardiovascular, renal, hepatic, respiratory, dermatological or gastrointestinal disease, and neurological or psychiatric disorder * History of cholecystectomy or gall stones * History of GI surgery * Acute diarrhoea or constipation in the 7 days before the predicted Day 1 * Participants who do not have suitable veins for multiple venepunctures/cannulation * Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis * Evidence of renal impairment at screening * Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1 * Participants who have previously been administered IMP in this study * Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years * Participants who have been administered IMP in an ADME study in the last 12 months * Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood * Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing * Current smokers or known or suspected history of alcohol or drug abuse * Excessive intake of caffeine-containing drinks or food

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07812077). StuddyBuddy aggregates publicly available trial information.