HealthyPhase 1NCT03400995
A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529
A Phase 1 study testing AK0529 in people with Healthy, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in United Kingdom.
Trial summary
This phase I study is to assess the mass balance recovery after a single oral dose of [14C]-AK0529 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AK0529
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2018to 30 Aug 2018
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Aged between 30 and 55 years of age, inclusive
- Body mass index of 18.0 to 35.0 kg/m2, inclusive, or, if outside the range, considered not clinically significant by the investigator and the medical monitor
- Must be willing and able to communicate and participate in the whole study
- Must have regular daily bowel movements
- Must provide written informed consent
- Must agree to use an adequate method of contraception
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who are study site or sponsor employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week
- Current smokers and those who have smoked within the last 12 months
Show all 21Show fewer
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Radiation exposure. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Abnormal liver function as assessed by clinical chemistry
- Positive drugs of abuse test result
- Positive HBsAg, HCV Ab or HIV results
- Evidence of renal impairment at screening
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, neurological, dermatological or GI disease, or psychiatric disorder, as judged by the investigator
- Any abnormality of ECG parameters
- Any abnormality of cardiac rhythm or history thereof
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed, unless it is active at screening or admission
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal or any other 'alternative' remedies in the 14 days before IMP administration
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-AK0529 in Healthy Male Subjects
This phase I study is to assess the mass balance recovery after a single oral dose of [14C]-AK0529 in healthy male subjects.
Read the detailed description
This is a single centre, single-dose, non-randomised, open label study. The primary objectives of this study are to assess the mass balance recovery and provide biosamples for metabolite profiling and structural identification after a single oral dose of [14C]-AK0529 in healthy male subjects. 7 subjects will be recruited to receive a single oral administration of a solution containing 300 mg AK0529. The total duration of the study will be approximately 6 weeks.
- Conditions
- Healthy
- Being tested
- AK0529
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK0529Drug
A solution containing 300 mg radiolabelled AK0529.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Each subject will receive a single oral administration of a solution containing 300 mg radiolabeled AK0529 in the fasted state. Receives: Drug: AK0529 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount excreted (Ae)
The amount of total radioactivity eliminated.
Measured: At approximately 6 weeks
Percentage of the administered dose (%Ae)
The amount of total radioactivity eliminated expressed as a percentage of the dose administered.
Measured: At approximately 6 weeks
Cumulative recovery (CumAe)
The cumulative amount of total radioactivity eliminated.
Measured: At approximately 6 weeks
Percentage of cumulative recovery of the administered dose (Cum%Ae)
The cumulative amount of total radioactivity eliminated expressed as a percentage of the dose administered.
Measured: At approximately 6 weeks
Secondary outcomes (1)
Percentage of Subjects with Adverse Events (AEs)
An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Measured: From baseline up to approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start5 Jan 2018
- Primary completion27 Feb 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ArkBio Clinical Trial, Study director, info@arkbiosciences.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400995
- Sponsor's protocol ID
- AK0529-4001
- Status last verified
- Sep 2018
- First submitted
- 10 Jan 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-AK0529 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03400995
- Acronym / sponsor ID
- AK0529-4001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 17 Jan 2018 (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 phase I study is to assess the mass balance recovery after a single oral dose of [14C]-AK0529 in healthy male subjects.
Detailed description
This is a single centre, single-dose, non-randomised, open label study. The primary objectives of this study are to assess the mass balance recovery and provide biosamples for metabolite profiling and structural identification after a single oral dose of [14C]-AK0529 in healthy male subjects. 7 subjects will be recruited to receive a single oral administration of a solution containing 300 mg AK0529. The total duration of the study will be approximately 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: AK0529Each subject will receive a single oral administration of a solution containing 300 mg radiolabeled AK0529 in the fasted state. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males
- Aged between 30 and 55 years of age, inclusive
- Body mass index of 18.0 to 35.0 kg/m2, inclusive, or, if outside the range, considered not clinically significant by the investigator and the medical monitor
- Must be willing and able to communicate and participate in the whole study
- Must have regular daily bowel movements
Key exclusion criteria (21 listed)
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who are study site or sponsor employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week
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 |
|---|---|---|
| AK0529A solution containing 300 mg radiolabelled AK0529. | Drug | Intervention Arm |
Primary outcome
Amount excreted (Ae)
Time frame: At approximately 6 weeks
The amount of total radioactivity eliminated.
Percentage of the administered dose (%Ae)
Time frame: At approximately 6 weeks
The amount of total radioactivity eliminated expressed as a percentage of the dose administered.
Cumulative recovery (CumAe)
Time frame: At approximately 6 weeks
The cumulative amount of total radioactivity eliminated.
Percentage of cumulative recovery of the administered dose (Cum%Ae)
Time frame: At approximately 6 weeks
The cumulative amount of total radioactivity eliminated expressed as a percentage of the dose administered.
1 secondary outcome
Percentage of Subjects with Adverse Events (AEs)
Time frame: From baseline up to approximately 6 weeks
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 11 Sep 2018.
- Individual participant dataSharing planned: No
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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.
ArkBio Clinical Trial study director
info@arkbiosciences.com
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 AK0529 in people with Healthy, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in United Kingdom.
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 7 inclusion and 21 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 11 Sep 2018. 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 Kingdom. 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?
Amount excreted (Ae) (time frame: At approximately 6 weeks). The study lists 4 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 11 Sep 2018.