Healthy VolunteersNCT04441450
ADME Study of [14C]ICP-022 in Healthy Males
A study testing [14C]ICP-022 in people with Healthy Volunteers, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to investigate the absorption, the metabolic pathways and the excretion of ICP-022 in healthy male adult participants after administration of a single oral dose of 150 mg of 14C ICP-022. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]ICP-022
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 6 Aug 2019
- Phase
- Interventional
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight: Body mass index (BMI) is 19~26 kg/m2
- signing of informed consent
- Volunteers are able to communicate well with the investigators and be able to complete the trial according to the process
Who cannot join
- physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, blood coagulation routine, urine routine, stool routine + occult blood, serum amylase, thyroid function, etc.), 12-lead ECG, Chest X-ray (Anteroposterior), abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) and other abnormalities and clinical significance.
- ophthalmologic examination shows abnormality and clinical significance
- Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, positive test for Syphilis antibody.
- Within 1 month before the screening, having not limited to known as hepatic enzyme inducers, inhibitors or substrates; (eg, inducer - barbiturate, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals) ;
- Within 1 month before the screening, receiving the anticoagulant therapy such as warfarin or thrombin inhibitor and/or aspirin antiplatelet therapy
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Absorption, Metabolism, and Excretion of Oral 14C Radiolabeled ICP-022: An Open-Label, Phase I, Single-Dose Study in Healthy Males
The purpose of this study is to investigate the absorption, the metabolic pathways and the excretion of ICP-022 in healthy male adult participants after administration of a single oral dose of 150 mg of 14C ICP-022.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]ICP-022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]ICP-022Drug
150mg suspension containing 100μCi of [14C]ICP-022
| Study group | Role | What they receive |
|---|---|---|
| [14C]ICP-022 | Experimental | Subjects will take a single of 150mg 100μCi of [14C]ICP-022. Receives: Drug: [14C]ICP-022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022
To investigate the pharmacokinetics of total radioactivity in plasma after oral [14C] ICP-022 in healthy volunteers, and the distribution ratio of total radioactivity in whole blood and plasma.
Measured: Up to14 days
Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers
Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers, obtaining body material balance data and main excretion pathways
Measured: Up to14 days
Secondary outcomes (2)
Quantitative analysis of the concentration of ICP-022 in plasma
Quantitative analysis of the concentration of ICP-022 in plasma to obtain the pharmacokinetic parameters of ICP-022
Measured: Up to14 days
The biotransformation pathways of [14C]ICP-022
Urine and fecal collection for metabolite profiling. Identify the main metabolites in humans after oral [14]ICP-022 in healthy volunteers to determine the main biotransformation pathways.
Measured: Up to14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jul 2019
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
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 Beijing InnoCare Pharma Tech Co., Ltd.The 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441450
- Sponsor's protocol ID
- ICP-CL-00110
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 22 Jun 2020
- 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 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption, Metabolism, and Excretion of Oral 14C Radiolabeled ICP-022: An Open-Label, Phase I, Single-Dose Study in Healthy Males
- ClinicalTrials.gov ID
- NCT04441450
- Acronym / sponsor ID
- ICP-CL-00110
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 22 Jun 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.
The purpose of this study is to investigate the absorption, the metabolic pathways and the excretion of ICP-022 in healthy male adult participants after administration of a single oral dose of 150 mg of 14C ICP-022.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]ICP-022 | Experimental | Drug: [14C]ICP-022Subjects will take a single of 150mg 100μCi of [14C]ICP-022. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Weight: Body mass index (BMI) is 19~26 kg/m2
- signing of informed consent
- Volunteers are able to communicate well with the investigators and be able to complete the trial according to the process
Key exclusion criteria (6 listed)
- physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, blood coagulation routine, urine routine, stool routine + occult blood, serum amylase, thyroid function, etc.), 12-lead ECG, Chest X-ray (Anteroposterior), abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) and other abnormalities and clinical significance.
- ophthalmologic examination shows abnormality and clinical significance
- Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, positive test for Syphilis antibody.
- Within 1 month before the screening, having not limited to known as hepatic enzyme inducers, inhibitors or substrates; (eg, inducer - barbiturate, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals) ;
- Within 1 month before the screening, receiving the anticoagulant therapy such as warfarin or thrombin inhibitor and/or aspirin antiplatelet therapy
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]ICP-022150mg suspension containing 100μCi of [14C]ICP-022 | Drug | [14C]ICP-022 |
Primary outcome
Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022
Time frame: Up to14 days
To investigate the pharmacokinetics of total radioactivity in plasma after oral [14C] ICP-022 in healthy volunteers, and the distribution ratio of total radioactivity in whole blood and plasma.
Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers
Time frame: Up to14 days
Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers, obtaining body material balance data and main excretion pathways
2 secondary outcomes
Quantitative analysis of the concentration of ICP-022 in plasma
Time frame: Up to14 days
The biotransformation pathways of [14C]ICP-022
Time frame: Up to14 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 22 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [14C]ICP-022 in people with Healthy Volunteers, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
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 3 inclusion and 6 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 22 Jun 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 China. 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.
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?
Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022 (time frame: Up to14 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 22 Jun 2020.