HealthyPhase 1NCT04467203
Evaluate the Effects of Food on the Pharmacokinetics of Fadanafil in Healthy Subjects
A Phase 1 study testing Fadanafil in people with Healthy, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of high fat meal on the pharmacokinetics of single oral fadanafil tablet 100mg in healthy subjects. Fadanafil is a selective phosphodiesterase (PDE5) inhibitor. 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
- What is being tested?
- Fadanafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2019to 28 Jun 2019
- 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 subjects 18-45 years old, inclusive.
- Body weight ≥50kg and Body Mass Index: 19.0~26.0 kg/m2, inclusive
- The vital signs (body temperature, systolic and diastolic blood pressure, heart rate and respiration) were in the normal range, and the normal value range of each vital sign was: (1) body temperature (underarm) 36.3 ~ 37.2 ℃; (2) 90mmHg ≤ systolic blood pressure < 140mmHg; (3) 60mmhg ≤ diastolic blood pressure < 90mmHg; (4) 50th / min ≤ heart rate ≤ 90th / min.
- Before the test, a comprehensive physical examination, laboratory examination and other auxiliary examinations were carried out, and the results were normal or abnormal but of no clinical significance. The ECG QTcF < 450 ms.
- Subjects should be willing to take appropriate contraceptive measures during the period of taking the study drug and within 6 months after discontinuation to avoid pregnancy of their partners.
- Subjects understand and will comply with the study procedure, participated voluntarily and signed the informed consent.
Who cannot join
- Subjects who have a history of clinical significant drug allergy (especially those who are known or suspected to have a history of allergy to any PDE-5 inhibitor or its components) or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or severe allergic constitution.
- History of clinically significant ECG abnormality or family history of long QT syndrome (grandparents, parents, brothers and sisters).
- Subjects with severe systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular diseases or mental disorders.
- Subjects with concominant diseases that may affect drug absorption, distribution, metabolism, excretion and safety evaluation, or reduce compliance.
- The test results of human immunodeficiency virus (HIV) antibody or hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or syphilis are positive.
- Subjects who have used over-the-counter drugs, health products, Chinese herbal medicine or traditional Chinese medicine within 2 weeks before screening, or who are taking foods that affect CYP3A4, such as grapefruit or drinks containing grapefruit (except those who occasionally take paracetamol orally, but the total maximum dose cannot exceed 1g, and the drug is not allowed to take orally within 48 hours prio to first dose).
- Subjects who had used any prescription drugs (especially CYP3A4 inhibitors, nitrates, α receptor blockers, drugs potential to cause QT interval prolongation, etc.) within 4 weeks before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Open-label, Two-period Crossover Phase 1b Study to Evaluate the Effect of Food on the Pharmacokinetics of Single Oral Fadanafil Tablet in Healthy Subjects
The purpose of this study is to evaluate the effect of high fat meal on the pharmacokinetics of single oral fadanafil tablet 100mg in healthy subjects.
Fadanafil is a selective phosphodiesterase (PDE5) inhibitor. The proposed Phase 1b trial is a single center, randomized, open-label, two-period crossover study in approximately 14 Chinese healthy adult male subjects.
- Conditions
- Healthy
- Being tested
- Fadanafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FadanafilDrug
Seven subjects in group A will receive treatment in the following order:
At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting->
At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal;Seven subjects in group B will receive treatment in the following order:
At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting
| Study group | Role | What they receive |
|---|---|---|
| Fadanafil fast to fat meal | Experimental | Seven subjects in group A will receive treatment in the following order:
At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting-> At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal Receives: Drug: Fadanafil |
| Fadanfil fat meal to fat | Experimental | Seven subjects in group B will receive treatment in the following order:
At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting Receives: Drug: Fadanafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter AUC(0-24)
AUC(0-24) of Fadanafile is area usder the curve
Measured: Pre dose and 0.25, 0.5, 0.75, 1,1.5,2,2.5,4,6,8,12,24,36 hours
Secondary outcomes (1)
Electrocardiogram (ECG) QT interval Safety and tolerability
To evaluate subject ECG QT interval Changing information
Measured: Change from Baseline to 1, 2, 4, 6, 8, 12, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start28 Apr 2019
- Primary completion14 May 2019
- Study completion28 Jun 2019
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467203
- Sponsor's protocol ID
- 5849-CPK-1002
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open-label, Two-period Crossover Phase 1b Study to Evaluate the Effect of Food on the Pharmacokinetics of Single Oral Fadanafil Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04467203
- Acronym / sponsor ID
- 5849-CPK-1002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2019 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 10 Jul 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 evaluate the effect of high fat meal on the pharmacokinetics of single oral fadanafil tablet 100mg in healthy subjects.
Fadanafil is a selective phosphodiesterase (PDE5) inhibitor. The proposed Phase 1b trial is a single center, randomized, open-label, two-period crossover study in approximately 14 Chinese healthy adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fadanafil fast to fat meal | Experimental | Drug: FadanafilSeven subjects in group A will receive treatment in the following order: At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting-> At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal |
| Fadanfil fat meal to fat | Experimental | Drug: FadanafilSeven subjects in group B will receive treatment in the following order: At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male subjects 18-45 years old, inclusive.
- Body weight ≥50kg and Body Mass Index: 19.0~26.0 kg/m2, inclusive
- The vital signs (body temperature, systolic and diastolic blood pressure, heart rate and respiration) were in the normal range, and the normal value range of each vital sign was: (1) body temperature (underarm) 36.3 ~ 37.2 ℃; (2) 90mmHg ≤ systolic blood pressure < 140mmHg; (3) 60mmhg ≤ diastolic blood pressure < 90mmHg; (4) 50th / min ≤ heart rate ≤ 90th / min.
- Before the test, a comprehensive physical examination, laboratory examination and other auxiliary examinations were carried out, and the results were normal or abnormal but of no clinical significance. The ECG QTcF < 450 ms.
- Subjects should be willing to take appropriate contraceptive measures during the period of taking the study drug and within 6 months after discontinuation to avoid pregnancy of their partners.
Key exclusion criteria (7 listed)
- Subjects who have a history of clinical significant drug allergy (especially those who are known or suspected to have a history of allergy to any PDE-5 inhibitor or its components) or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or severe allergic constitution.
- History of clinically significant ECG abnormality or family history of long QT syndrome (grandparents, parents, brothers and sisters).
- Subjects with severe systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular diseases or mental disorders.
- Subjects with concominant diseases that may affect drug absorption, distribution, metabolism, excretion and safety evaluation, or reduce compliance.
- The test results of human immunodeficiency virus (HIV) antibody or hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or syphilis are 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 |
|---|---|---|
| FadanafilSeven subjects in group A will receive treatment in the following order: At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting-> At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal;Seven subjects in group B will receive treatment in the following order: At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting | Drug | Fadanafil fast to fat meal, Fadanfil fat meal to fat |
Primary outcome
Pharmacokinetic Parameter AUC(0-24)
Time frame: Pre dose and 0.25, 0.5, 0.75, 1,1.5,2,2.5,4,6,8,12,24,36 hours
AUC(0-24) of Fadanafile is area usder the curve
1 secondary outcome
Electrocardiogram (ECG) QT interval Safety and tolerability
Time frame: Change from Baseline to 1, 2, 4, 6, 8, 12, 24 hours
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 10 Jul 2020.
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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 Fadanafil in people with Healthy, run by Sihuan Pharmaceutical Holdings Group 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 7 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 10 Jul 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.
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?
Pharmacokinetic Parameter AUC(0-24) (time frame: Pre dose and 0.25, 0.5, 0.75, 1,1.5,2,2.5,4,6,8,12,24,36 hours). 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 10 Jul 2020.