Clinical trial NCT04225208: Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Dizal Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: Up to 57 days
measure: Provide samples for subsequent studies
timeFrame: Up to 57 days
Secondary outcomes:
measure: AUC(0-inf) for [14C] radioactivity in plasma and whole blood
timeFrame: Up to 57 days
measure: AUC(0-t) for [14C] radioactivity in plasma and whole blood
timeFrame: Up to 57 days
measure: Cmax for [14C] radioactivity in plasma and whole blood
timeFrame: Up to 57 days
measure: tmax for [14C] radioactivity in plasma and whole blood
timeFrame: Up to 57 days
measure: tlag for [14C] radioactivity in plasma and whole blood
timeFrame: Up to 57 days
measure: t1/2 for [14C] radioactivity in plasma and whole blood
timeFrame: Up to 57 days
measure: λz for [14C] radioactivity in plasma and whole blood
timeFrame: Up to 57 days
measure: CL/F for [14C] radioactivity in plasma and whole blood
timeFrame: Up to 57 days
measure: Vss/F for [14C] radioactivity in plasma and whole blood
timeFrame: Up to 57 days
measure: Distribution of total radioactivity in blood
timeFrame: Up to 57 days
Other outcomes:
measure: Number of participants with treatment-related adverse events, and serious adverse events
timeFrame: Up to 57 days
Locations:
city: Baltimore
country: United States
facility: Pharmaron CPC
state: Maryland
Study officials:
affiliation: Pharmaron CPC
name: Royce Morrison
role: PRINCIPAL_INVESTIGATOR
References: