Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Volunteers

A Phase I, Single-centre, Non-Randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Subjects

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C]-AZD4205.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-AZD4205, single 50 mg oral dose administrated on day 1

Detailed Description

Phase I study to evaluate the excretion of AZD4205 radioactive dose, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]-AZD4205 in healthy male volunteers. The purpose of this study is to investigate ADME properties of AZD4205 by analyzing blood, urine and feces collected during the study

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron CPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 1. Healthy male subjects aged 18 to 65, who must be willing to use reliable methods of contraception, even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil.
• 2. In addition, subjects must agree to continue to take similar contraceptive precautions until 6 months after administration of AZD4205 and avoid procreative sex as well as sperm donation for 6 months after administration of AZD4205.

Exclusion Criteria:

• 1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at screening or baseline in the opinion of the investigator.
• 2. Subjects who may have been exposed to radiation for therapeutic or diagnostic reasons at levels above background (e.g,, through X-ray examination other than dental X-rays or plain X-rays of thorax or bony skeleton) of > 5 mSv in last year, > 10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-AZD4205; A single dose of [14C]-AZD4205	Drug: [14C]-AZD4205, single 50 mg oral dose administrated on day 1; Each subject will receive 50 mg AZD4205 oral solution (free base equivalent) containing a nominal dose of 15 µCi [14C]- radiolabelled AZD4205 as a single administration .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of radioactive dose recovered in urine and faeces and total percentage	To evaluate the percentage of radioactive dose of [14C] radiolabelled AZD4205 recovered in urine, feces, and in total	Up to 57 days
Provide samples for subsequent studies	Provide samples for subsequent studies to characterize the metabolism of [14C]AZD4205	Up to 57 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-inf) for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting AUC(0-inf)	Up to 57 days
AUC(0-t) for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting AUC(0-t)	Up to 57 days
Cmax for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting Cmax	Up to 57 days
tmax for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting tmax	Up to 57 days
tlag for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting tlag	Up to 57 days
t1/2 for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting t1/2	Up to 57 days
λz for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting λz	Up to 57 days
CL/F for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting CL/F	Up to 57 days
Vss/F for [14C] radioactivity in plasma and whole blood	To determine AZD4205 plasma concentrations and the resulting Vss/F	Up to 57 days
Distribution of total radioactivity in blood	To compare disposition of drug-related total radioactivity in whole blood to that in plasma	Up to 57 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events, and serious adverse events	To assess the safety and tolerability of a single dose of AZD4205 in healthy adult male subjects.	Up to 57 days

Collaborators and Investigators

• Sponsor: Dizal Pharmaceuticals
• Investigators: Principal Investigator: Royce Morrison, Pharmaron CPC

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DZ2019J0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No