Healthy VolunteersPhase 1NCT04225208
Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Volunteers
A Phase 1 study testing [14C]-AZD4205, single 50 mg oral dose administrated on day 1 in people with Healthy Volunteers, run by Dizal Pharmaceuticals at 1 site in United States.
Trial summary
This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C]-AZD4205. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-AZD4205, single 50 mg oral dose administrated on day 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 2 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C]-AZD4205.
Read the 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
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-AZD4205, single 50 mg oral dose administrated on day 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-AZD4205, single 50 mg oral dose administrated on day 1Drug
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 .
| Study group | Role | What they receive |
|---|---|---|
| [14C]-AZD4205 | Experimental | A single dose of [14C]-AZD4205 Receives: Drug: [14C]-AZD4205, single 50 mg oral dose administrated on day 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 57 days
Provide samples for subsequent studies
Provide samples for subsequent studies to characterize the metabolism of [14C]AZD4205
Measured: Up to 57 days
Secondary outcomes (10)
AUC(0-inf) for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting AUC(0-inf)
Measured: Up to 57 days
AUC(0-t) for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting AUC(0-t)
Measured: Up to 57 days
Cmax for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting Cmax
Measured: Up to 57 days
tmax for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting tmax
Measured: Up to 57 days
tlag for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting tlag
Measured: Up to 57 days
t1/2 for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting t1/2
Measured: Up to 57 days
λz for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting λz
Measured: Up to 57 days
CL/F for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting CL/F
Measured: Up to 57 days
Vss/F for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting Vss/F
Measured: Up to 57 days
Distribution of total radioactivity in blood
To compare disposition of drug-related total radioactivity in whole blood to that in plasma
Measured: Up to 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start6 Jan 2020
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Royce Morrison, Principal investigator, Pharmaron CPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225208
- Sponsor's protocol ID
- DZ2019J0002
- Status last verified
- Dec 2019
- First submitted
- 3 Jan 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04225208
- Acronym / sponsor ID
- DZ2019J0002
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-AZD4205 | Experimental | Drug: [14C]-AZD4205, single 50 mg oral dose administrated on day 1A single dose of [14C]-AZD4205 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-AZD4205, single 50 mg oral dose administrated on day 1Each 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 . | Drug | [14C]-AZD4205 |
Primary outcome
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: 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
Time frame: Up to 57 days
Provide samples for subsequent studies to characterize the metabolism of [14C]AZD4205
10 secondary outcomes
AUC(0-inf) for [14C] radioactivity in plasma and whole blood
Time frame: Up to 57 days
AUC(0-t) for [14C] radioactivity in plasma and whole blood
Time frame: Up to 57 days
Cmax for [14C] radioactivity in plasma and whole blood
Time frame: Up to 57 days
tmax for [14C] radioactivity in plasma and whole blood
Time frame: Up to 57 days
tlag for [14C] radioactivity in plasma and whole blood
Time frame: Up to 57 days
t1/2 for [14C] radioactivity in plasma and whole blood
Time frame: Up to 57 days
λz for [14C] radioactivity in plasma and whole blood
Time frame: Up to 57 days
CL/F for [14C] radioactivity in plasma and whole blood
Time frame: Up to 57 days
Vss/F for [14C] radioactivity in plasma and whole blood
Time frame: Up to 57 days
Distribution of total radioactivity in blood
Time frame: Up to 57 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Royce Morrison principal investigator
Pharmaron CPC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-AZD4205, single 50 mg oral dose administrated on day 1 in people with Healthy Volunteers, run by Dizal Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of radioactive dose recovered in urine and faeces and total percentage (time frame: Up to 57 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.