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

• Sponsor: Dizal Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04225208
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: [14C]-AZD4205, single 50 mg oral dose administrated on day 1	Phase 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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Phase I, Single-centre, Non-Randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Subjects
• Actual Study Start Date: Jan 6, 2020
• Actual Primary Completion Date: Mar 2, 2020
• Actual Study Completion Date: Mar 2, 2020

Arms and Interventions

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 .

Outcome Measures

Primary Outcome Measures

1. Percentage of radioactive dose recovered in urine and faeces and total percentage [Up to 57 days]

   To evaluate the percentage of radioactive dose of [14C] radiolabelled AZD4205 recovered in urine, feces, and in total

2. Provide samples for subsequent studies [Up to 57 days]

   Provide samples for subsequent studies to characterize the metabolism of [14C]AZD4205

Secondary Outcome Measures

1. AUC(0-inf) for [14C] radioactivity in plasma and whole blood [Up to 57 days]

   To determine AZD4205 plasma concentrations and the resulting AUC(0-inf)

2. AUC(0-t) for [14C] radioactivity in plasma and whole blood [Up to 57 days]

   To determine AZD4205 plasma concentrations and the resulting AUC(0-t)

3. Cmax for [14C] radioactivity in plasma and whole blood [Up to 57 days]

   To determine AZD4205 plasma concentrations and the resulting Cmax

4. tmax for [14C] radioactivity in plasma and whole blood [Up to 57 days]

   To determine AZD4205 plasma concentrations and the resulting tmax

5. tlag for [14C] radioactivity in plasma and whole blood [Up to 57 days]

   To determine AZD4205 plasma concentrations and the resulting tlag

6. t1/2 for [14C] radioactivity in plasma and whole blood [Up to 57 days]

   To determine AZD4205 plasma concentrations and the resulting t1/2

7. λz for [14C] radioactivity in plasma and whole blood [Up to 57 days]

   To determine AZD4205 plasma concentrations and the resulting λz

8. CL/F for [14C] radioactivity in plasma and whole blood [Up to 57 days]

   To determine AZD4205 plasma concentrations and the resulting CL/F

9. Vss/F for [14C] radioactivity in plasma and whole blood [Up to 57 days]

   To determine AZD4205 plasma concentrations and the resulting Vss/F

10. Distribution of total radioactivity in blood [Up to 57 days]

    To compare disposition of drug-related total radioactivity in whole blood to that in plasma

Other Outcome Measures

1. Number of participants with treatment-related adverse events, and serious adverse events [Up to 57 days]

   To assess the safety and tolerability of a single dose of AZD4205 in healthy adult male subjects.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.
• 1. 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.
• 1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharmaron CPC	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Dizal Pharmaceuticals

Investigators

• Principal Investigator: Royce Morrison, Pharmaron CPC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dizal Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04225208
• Other Study ID Numbers: DZ2019J0002
• First Posted: Jan 13, 2020
• Last Update Posted: Aug 24, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 24, 2020