Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Volunteers
- Conditions
- Healthy Volunteers
- Interventions
- Drug: [14C]-AZD4205, single 50 mg oral dose administrated on day 1
- Registration Number
- NCT04225208
- Lead Sponsor
- Dizal Pharmaceuticals
- Brief Summary
This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\]-AZD4205.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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- 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.
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- 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.
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- 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.
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- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]-AZD4205 [14C]-AZD4205, single 50 mg oral dose administrated on day 1 A single dose of \[14C\]-AZD4205
- Primary Outcome Measures
Name Time Method 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
Provide samples for subsequent studies Up to 57 days Provide samples for subsequent studies to characterize the metabolism of \[14C\]AZD4205
- Secondary Outcome Measures
Name Time Method 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)
tmax for [14C] radioactivity in plasma and whole blood Up to 57 days To determine AZD4205 plasma concentrations and the resulting tmax
tlag for [14C] radioactivity in plasma and whole blood Up to 57 days To determine AZD4205 plasma concentrations and the resulting tlag
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
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)
Cmax for [14C] radioactivity in plasma and whole blood Up to 57 days To determine AZD4205 plasma concentrations and the resulting Cmax
t1/2 for [14C] radioactivity in plasma and whole blood Up to 57 days To determine AZD4205 plasma concentrations and the resulting t1/2
λz for [14C] radioactivity in plasma and whole blood Up to 57 days To determine AZD4205 plasma concentrations and the resulting λz
CL/F for [14C] radioactivity in plasma and whole blood Up to 57 days To determine AZD4205 plasma concentrations and the resulting CL/F
Vss/F for [14C] radioactivity in plasma and whole blood Up to 57 days To determine AZD4205 plasma concentrations and the resulting Vss/F
Trial Locations
- Locations (1)
Pharmaron CPC
🇺🇸Baltimore, Maryland, United States