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Healthy ParticipantsPhase 1NCT06157918

Relative Bioavailability and Food Effect of SYHA1813 Oral Solution in Healthy Participants

A Phase 1 study testing SYHA1813 oral solution (2.0g:25mg) and SYHA1813 oral solution (20ml:200mg) in people with Healthy Participants, run by Shanghai Runshi Pharmaceutical Technology 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 three-period crossover phase I study designed to evaluate the relative bioavailability, food effect, safety and tolerability of SYHA1813 oral solution in healthy participants. Read more about this study

Who is it for?
Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
SYHA1813 oral solution (2.0g:25mg) and SYHA1813 oral solution (20ml:200mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
20 Dec 2023to 26 Jan 2024
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 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male aged 18 to 60 years old;
  • Weight more than 50.0 kg and body mass index between 19 to 26.0 kg/m^2;
  • Normal or abnormal results without clinical significance on all tests including medical history, vital signs, physical examination, laboratory evaluation (routine blood, blood biochemistry, urine routine, coagulation function, serum virology, and other related tests), 12-lead electrocardiogram, chest X-ray and other tests;
  • Male participants and their partners must agree to use effective non-hormonal contraception from the first administration of the test drug to 6 months after the last administration of the test drug, even if permanent contraception has already been used, and the male participant does not plan to donate sperm;
  • Voluntarily sign the informed consent form, and cooperate in completing the trial according to the protocol.

Who cannot join

  • Allergic constitution (allergic to 2 or more kinds of drugs, food, or pollen);
  • Participants with a clear history of neurological disease or psychiatric disease, a history of severe cardiovascular, hepatic, renal, endocrine, respiratory, hematologic, digestive, immune, and other various systemic diseases, or a history of malignant neoplastic disease;
  • Participants who are unable to swallow orally administered drugs, or clinically significant abnormalities in gastrointestinal function that could affect drug absorption, distribution, metabolism, and excretion;
  • Participants who have undergone major surgery within 6 months prior to screening or who are scheduled to undergo surgery during the trial;
  • Participants with 1 or more abnormal vital signs at screening;
  • Abnormal and clinically significant electrocardiograms: QTc interval >450ms;
Show all 18Show fewer
  • Participants who consumed more than 14 units of alcohol per week in the 4 weeks prior to screening or who had a positive breath test for alcohol at screening;
  • Smoking ≥ 5 cigarettes per day on average within 6 months prior to screening;
  • Participants with a history of drug or substance abuse, or a positive urine drug screen;
  • Participants who have lost blood or donated more than 400 ml of blood within 4 weeks prior to screening or plan to donate blood during the study or within 1 month of the end of the study;
  • Participants who have participated in other clinical trials within 3 months prior to screening;
  • Habitual intake of excessive xanthine or caffeine-containing foods, beverages, or other foods that interfere with drug absorption, distribution, metabolism, excretion within 4 weeks prior to screening;
  • Participants who have taken a special diet (dragon fruit, mango, grapefruit, lime, poppy seed, or food or drink prepared from them) within 7 days prior to screening, or participants who are unable to stop taking the above special diets during the trial;
  • Participants who have used potent inhibitors or inducers of CYP enzymes (e.g., CYP2C9, 2C19, and 3A4) within 4 weeks prior to screening;
  • Participants who have used prescription, over-the-counter, herbal, vitamin, or mineral medications within 2 weeks prior to screening, and participants who have taken medications prior to screening that have not completed 5 half-lives, whichever is longer among the various medications;
  • Participants who cannot tolerate venipuncture or with a history of fainting needle or blood;
  • Participants who are lactose intolerant;
  • Any condition that the investigator considers inappropriate for participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Shanghai

Other trials in China

About this study

Official title: A Single-Center, Randomized, Open-label, Single-dose, 3-Sequence, 3-Period Rossover Design to Evaluate the Relative Bioavailability and Food Effect of SYHA1813 Oral Solution in Healthy Participants

This is a three-period crossover phase I study designed to evaluate the relative bioavailability, food effect, safety and tolerability of SYHA1813 oral solution in healthy participants.

Read the detailed description

Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.

Being tested
SYHA1813 oral solution (2.0g:25mg), SYHA1813 oral solution (20ml:200mg)

What participants receive

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

  • SYHA1813 oral solution (2.0g:25mg)Drug

    SYHA1813 oral solution, 25mg, oral

  • SYHA1813 oral solution (20ml:200mg)Drug

    SYHA1813 oral solution, 25mg, oral

Study groups in NCT06157918
Study groupRoleWhat they receive
Group 1-sequence ABCExperimentalParticipants will sequentially receive SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A), followed by SYHA1813 oral solution (20ml:200mg) fasted (Treatment B), and SYHA1813 oral solution (2.0g:25mg) fed (Treatment C).
Receives: Drug: SYHA1813 oral solution (2.0g:25mg); Drug: SYHA1813 oral solution (20ml:200mg)
Group 2-sequence BCAExperimentalParticipants will sequentially receive SYHA1813 oral solution (20ml:200mg) fasted (Treatment B), followed by SYHA1813 oral solution (2.0g:25mg) fed(Treatment C), and SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A).
Receives: Drug: SYHA1813 oral solution (2.0g:25mg); Drug: SYHA1813 oral solution (20ml:200mg)
Group 3-sequence CABExperimentalParticipants will sequentially receive SYHA1813 oral solution (2.0g:25mg) fed (Treatment C), followed by SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A), and SYHA1813 oral solution (20ml:200mg) fasted (Treatment B).
Receives: Drug: SYHA1813 oral solution (2.0g:25mg); Drug: SYHA1813 oral solution (20ml:200mg)

What is being measured

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

  1. Cmax

    Maximum observed plasma concentration

    Measured: Up to 120 hours post-dose for eachperiod

  2. AUC0-∞

    Area under the plasma concentration time curve from time zero extrapolated to infinite time

    Measured: Up to 120 hours post-dose for eachperiod

  3. AUC0-t

    Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration

    Measured: Up to 120 hours post-dose for eachperiod

Secondary outcomes (5)

  1. Tmax

    Time of maximum observed plasma concentration

    Measured: Up to 120 hours post-dose for eachperiod

  2. T1/2

    Terminal elimination half-life

    Measured: Up to 120 hours post-dose for eachperiod

  3. Title:Cl/F

    Apparent total body clearance

    Measured: Up to 120 hours post-dose for eachperiod

  4. V/F

    Apparent volume of distribution

    Measured: Up to 120 hours post-dose for eachperiod

  5. Number of participants with Adverse Events

    Measured: Up to 34 days

Timeline

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

  1. First posted6 Dec 2023
  2. Study start20 Dec 2023
  3. Primary completion26 Jan 2024
  4. Study completion26 Jan 2024

Resources

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
Randomised
Intervention model
Crossover
Model description
3-period Crossover Assignment
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06157918
Sponsor's protocol ID
SYHA1814-003
Status last verified
Nov 2024
First submitted
27 Nov 2023
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SYHA1813 oral solution (2.0g:25mg) and SYHA1813 oral solution (20ml:200mg) in people with Healthy Participants, run by Shanghai Runshi Pharmaceutical Technology 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 5 inclusion and 18 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 8 Nov 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?

Cmax (time frame: Up to 120 hours post-dose for eachperiod). The study lists 3 primary outcomes in all. 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 NCT06157918.

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 8 Nov 2024.

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