Healthy Male SubjectsPhase 1NCT05998304

ADME Study of [14C] Yiqibuvir in Healthy Male Subjects

A Phase 1 study testing [14C] Yiqibuvir in people with Healthy Male Subjects, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] Yiqibuvir. Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male Subjects
What is being tested?: [14C] Yiqibuvir
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 siteChina
Study dates: 7 Aug 2023to 12 Sep 2023
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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

signing of informed consent
Weight: Body mass index (BMI) is 19.0~28.0 kg/m2
Subjects are able to communicate well with the investigators and be able to complete the trial according to the process

Who cannot join

Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations
Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive
Positive results from urine drug screen test
Donate blood or lose blood 400 mL or more within 3 month prior to dosing
Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication
History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai xuhui central hospital
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Yiqibuvir in Healthy Male Participants

This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] Yiqibuvir.

Conditions: Healthy Male Subjects
Being tested: [14C] Yiqibuvir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C] YiqibuvirDrug
600 mg suspension containing 100µCi of [14C] Yiqibuvir

Study groups in NCT05998304
Study group	Role	What they receive
[14C] Yiqibuvir	Experimental	Eligible healthy male subjects received a single oral 600 mg (radioactivity of 100µCi) dose of [14C] Yiqibuvir Receives: Drug: [14C] Yiqibuvir

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Measured: up to 18 days

Secondary outcomes (3)

Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir
Proportion of different metabolites(Yiqibuvir and main metabolites）
Measured: up to 18 days
Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
The concentrations of Yiqibuvir and main metabolites in plasma
Measured: up to 18 days
Number of adverse events (AE) experienced by subjects
To examine the safety and tolerability of [14C] Yiqibuvir given orally
Measured: up to 18 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 202312 Sep 2023

First posted18 Aug 2023
Study start7 Aug 2023
Primary completion12 Sep 2023
Study completion12 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
More trials run by Sunshine Lake Pharma 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 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05998304
Sponsor's protocol ID: HEC110114-HCV-103/CRC-C2314
Status last verified: Jul 2023
First submitted: 26 Jul 2023
Last updated: 21 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Male Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Yiqibuvir in Healthy Male Participants
ClinicalTrials.gov ID: NCT05998304
Acronym / sponsor ID: HEC110114-HCV-103/CRC-C2314
Conditions: Healthy Male Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 Aug 2023 (actual)
Primary completion: 12 Sep 2023 (actual)
Study completion: 12 Sep 2023 (actual)
First posted: 18 Aug 2023 (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 single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] Yiqibuvir.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[14C] Yiqibuvir	Experimental	Drug: [14C] YiqibuvirEligible healthy male subjects received a single oral 600 mg (radioactivity of 100µCi) dose of [14C] Yiqibuvir

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

signing of informed consent
Weight: Body mass index (BMI) is 19.0~28.0 kg/m2
Subjects are able to communicate well with the investigators and be able to complete the trial according to the process

Key exclusion criteria (6 listed)

Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations
Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive
Positive results from urine drug screen test
Donate blood or lose blood 400 mL or more within 3 month prior to dosing
Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication

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] Yiqibuvir600 mg suspension containing 100µCi of [14C] Yiqibuvir	Drug	[14C] Yiqibuvir

Primary outcome

Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)
Time frame: up to 18 days
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.

3 secondary outcomes

Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir
Time frame: up to 18 days
Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
Time frame: up to 18 days
Number of adverse events (AE) experienced by subjects
Time frame: up to 18 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 21 Feb 2024.
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.

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 Phase 1 study testing [14C] Yiqibuvir in people with Healthy Male Subjects, run by Sunshine Lake Pharma 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 21 Feb 2024. 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.

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?

Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples) (time frame: up to 18 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05998304.

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 21 Feb 2024.