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

NCT04225208 | Completed Phase 1 FDA Drug

• 1 other identifier: DZ2019J0002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• AUC(0-inf) for [14C] radioactivity in plasma and whole blood

  Up to 57 days

• AUC(0-t) for [14C] radioactivity in plasma and whole blood

  Up to 57 days

• Cmax for [14C] radioactivity in plasma and whole blood

  Up to 57 days

• tmax for [14C] radioactivity in plasma and whole blood

  Up to 57 days

• tlag for [14C] radioactivity in plasma and whole blood

  Up to 57 days

Other Outcomes (1)

• Number of participants with treatment-related adverse events, and serious adverse events

  Up to 57 days

Study Arms (1)

[14C]-AZD4205

EXPERIMENTAL

A single dose of \[14C\]-AZD4205

Drug: [14C]-AZD4205, single 50 mg oral dose administrated on day 1

Interventions

[14C]-AZD4205, single 50 mg oral dose administrated on day 1 DRUG

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 .

[14C]-AZD4205

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.

You may not qualify if:

• \. 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.
• \. 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.

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (1)

Pharmaron CPC

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Royce Morrison

  Pharmaron CPC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 13, 2020
• Study Start: January 6, 2020
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: August 24, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)