Healthy Male VolunteersPhase 1NCT04808648
The Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SH-1028
A Phase 1 study testing SH-1028, Itraconazole and Rifampicin in people with Healthy Male Volunteers, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.
Trial summary
This is a phase I study to assess the drug-drug interaction of SH-1028 tablets and Itraconazole/Rifampicin tablets. The study also evaluates the pharmacokinetic and tolerability of SH-1028 tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols. 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 Male Volunteers
- What is being tested?
- SH-1028, Itraconazole and Rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2021to 30 Jun 2021
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers between the age of 18 to 45 years old (including 18 and 45 years old)
- Body weight between 50.0 and 80.0 kg, Body mass index between 19.0 and 26.0 kg/m2 (including 19.0 and 26.0 kg/m2);
- Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
- Promise not to smoke, drink alcohol or drink caffeinated beverages during the trial;
- Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.
- Male subjects of reproductive potential with partners will be instructed to,and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 6 months after discontinuing treatment with the investigational product.
Who cannot join
- History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder. Or any other disease or physiological condition that may affect the results of the study;
- Those who have undergone surgery within the first 3 months of the screening period, or who plan to undergo surgery during the study period, or who have previously undergone surgery that may affect drug absorption, distribution, metabolism, and excretion;
- Subjects with dysphagia or have history of gastrointestinal disorders which affects study drug absorption;
- Alcohol breath test results greater than 0.0mg/100mL.
- Urine drug screening (morphine, methamphetamine, ketamine, dimethyldioxyamphetamine, tetrahydrocannabinol) positive;
- Those who had received the vaccine within 28 days prior to screening, or who planned to receive the vaccine during the trial;
Show all 17Show fewer
- Positive test for HBs-Ag, HCV-Ab, HIV-Ab, or syphilis antibody;
- Allergies, have allergies to drugs or foods; or have known allergies to the components of the investigated drug;
- Those who smoked daily >5 sticks of cigarette, or the weekly alcohol consumption was higher than 14 units of alcohol (1 unit=10ml or 8g absolute alcohol. 25 ml 40% liquor, 330ml 5% beers, 175ml 12% grape wine are equal to 1.0, 1.5 and 2.0 units of alcohol respectively), or the history of drug abuse and drug abuseor 3 months prior to screening period;
- Subjects with history of blood donation or massive blood loss (> 200 mL) within 3 months prior to screening;
- Participated in other clinical trials within 3 months before screening;
- Use of any drugs that alter liver enzyme activity within 28 days prior to screening;
- Do not promise not to smoke, not drink alcoholic food or beverages, not consume xanthine-rich foods, not consume grapefruit, dragon fruit, mango, lime, carambola or other products within 24 hours before taking the study drug. Prepared foods or beverages, as well as chocolate, tea, coffee or cola and other special diets that affect the absorption, distribution, metabolism and excretion of drugs;
- People who have used any medicine (including Chinese herbal medicine and health care products) within two weeks before taking the test drug;
- History of syncope / needle syncope and intolerable intravenous indwelling needle;
- Those who have special requirements for diet and cannot follow a unified diet;
- hose who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital with Bengbu Medical College
Bengbu, Anhui, 233004
Huan Zhou, Ph D, 13665527160, zhouhuan@bbmc.edu.cn
Huan Zhou, Ph D
About this study
Official title: A Single-center, Open-label, Drug-drug Interaction Study of SH-1028 Tablets in Healthy Subjects
This is a phase I study to assess the drug-drug interaction of SH-1028 tablets and Itraconazole/Rifampicin tablets. The study also evaluates the pharmacokinetic and tolerability of SH-1028 tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols.
Read the detailed description
A total of 40 evaluable healthy male subjects will be enrolled in this study.The subjects will be divided into two groups, A and B, with 20 people in each group.
In the itraconazole study (Group A), patients received single-dose SH-1028 200 mg on Days 1 and 12 and itraconazole(200 mg twice daily) on Days 8-14 orally.
In the rifampicin study (Group B), patients received SH-1028 200mg once daily on Days 1 and 14 and rifampicin 600 mg once daily on Days 8-16.
- Conditions
- Healthy Male Volunteers
- Being tested
- SH-1028, Itraconazole, Rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH-1028Drug
tablet, oral, 200 mg once daily for day 1 and day 12
ItraconazoleDrug
capsule, oral, 200 mg twice daily for day 8 to day 14
RifampicinDrug
capsule, oral, 600 mg once daily for day 8 to day 16
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole and SH-1028 | Experimental | In the itraconazole study, patients received single-dose SH-1028 200 mg on Days 1 and 12 and itraconazole(200 mg twice daily) on Days 8-14 orally. Receives: Drug: SH-1028; Drug: Itraconazole |
| Rifampicin and SH-1028 | Experimental | In the rifampicin study, patients received SH-1028 200mg once daily on Days 1 and 14 and rifampicin 600 mg once daily on Days 8-16 Receives: Drug: SH-1028; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetics of SH-1028 by assessment of maximum plasma concentration
Measured: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose
AUC(0-last)
Pharmacokinetics of SH-1028 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint
Measured: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose
AUC(0-∞)
Pharmacokinetics of SH-1028 by assessment of area under the concentration time curve from time 0 to infinity
Measured: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose
Secondary outcomes (1)
Incidence of adverse events
Safety and tolerability
Measured: Up to 10 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start6 Apr 2021 (estimated)
- Primary completion10 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808648
- Sponsor's protocol ID
- SHC013-I-05
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Drug-drug Interaction Study of SH-1028 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04808648
- Acronym / sponsor ID
- SHC013-I-05
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2021 (estimated)
- Primary completion
- 10 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 22 Mar 2021 (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 study to assess the drug-drug interaction of SH-1028 tablets and Itraconazole/Rifampicin tablets. The study also evaluates the pharmacokinetic and tolerability of SH-1028 tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols.
Detailed description
A total of 40 evaluable healthy male subjects will be enrolled in this study.The subjects will be divided into two groups, A and B, with 20 people in each group.
In the itraconazole study (Group A), patients received single-dose SH-1028 200 mg on Days 1 and 12 and itraconazole(200 mg twice daily) on Days 8-14 orally.
In the rifampicin study (Group B), patients received SH-1028 200mg once daily on Days 1 and 14 and rifampicin 600 mg once daily on Days 8-16.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itraconazole and SH-1028 | Experimental | Drug: SH-1028, Drug: ItraconazoleIn the itraconazole study, patients received single-dose SH-1028 200 mg on Days 1 and 12 and itraconazole(200 mg twice daily) on Days 8-14 orally. |
| Rifampicin and SH-1028 | Experimental | Drug: SH-1028, Drug: RifampicinIn the rifampicin study, patients received SH-1028 200mg once daily on Days 1 and 14 and rifampicin 600 mg once daily on Days 8-16 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male volunteers between the age of 18 to 45 years old (including 18 and 45 years old)
- Body weight between 50.0 and 80.0 kg, Body mass index between 19.0 and 26.0 kg/m2 (including 19.0 and 26.0 kg/m2);
- Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
- Promise not to smoke, drink alcohol or drink caffeinated beverages during the trial;
- Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.
Key exclusion criteria (17 listed)
- History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder. Or any other disease or physiological condition that may affect the results of the study;
- Those who have undergone surgery within the first 3 months of the screening period, or who plan to undergo surgery during the study period, or who have previously undergone surgery that may affect drug absorption, distribution, metabolism, and excretion;
- Subjects with dysphagia or have history of gastrointestinal disorders which affects study drug absorption;
- Alcohol breath test results greater than 0.0mg/100mL.
- Urine drug screening (morphine, methamphetamine, ketamine, dimethyldioxyamphetamine, tetrahydrocannabinol) positive;
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 |
|---|---|---|
| SH-1028tablet, oral, 200 mg once daily for day 1 and day 12 | Drug | Itraconazole and SH-1028, Rifampicin and SH-1028 |
| Itraconazolecapsule, oral, 200 mg twice daily for day 8 to day 14 | Drug | Itraconazole and SH-1028 |
| Rifampicincapsule, oral, 600 mg once daily for day 8 to day 16 | Drug | Rifampicin and SH-1028 |
Primary outcome
Cmax
Time frame: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose
Pharmacokinetics of SH-1028 by assessment of maximum plasma concentration
AUC(0-last)
Time frame: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose
Pharmacokinetics of SH-1028 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint
AUC(0-∞)
Time frame: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose
Pharmacokinetics of SH-1028 by assessment of area under the concentration time curve from time 0 to infinity
1 secondary outcome
Incidence of adverse events
Time frame: Up to 10 days after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
Related trials for Healthy Male Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
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.
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 SH-1028, Itraconazole and Rifampicin in people with Healthy Male Volunteers, run by Nanjing Sanhome Pharmaceutical, 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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 22 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huan Zhou, Ph D (13665527160, zhouhuan@bbmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Blood samples collected on Day 1 and Day 12 (arm 1)/Day 14 (arm 2) at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post SH-1028 dose). 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?
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 Mar 2021.