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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT04225208

Run by

Dizal Pharmaceuticals

People needed

8

Starts

2020-01-06

Expected to finish

2020-03-02

Last updated by the study team

2020-08-24

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pharmaron CPC — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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