Evaluate the Effects of Food on the Pharmacokinetics of Fadanafil in Healthy Subjects

July 7, 2020 updated by: Sihuan Pharmaceutical Holdings Group Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100076
        • Haiyan Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fadanafil fast to fat meal

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
Drug: Fadanafil

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
Experimental: Fadanfil fat meal to fat

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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Pre dose and 0.25, 0.5, 0.75, 1,1.5,2,2.5,4,6,8,12,24,36 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electrocardiogram (ECG) QT interval Safety and tolerability
Time Frame: Change from Baseline to 1, 2, 4, 6, 8, 12, 24 hours
To evaluate subject ECG QT interval Changing information
Change from Baseline to 1, 2, 4, 6, 8, 12, 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sihuan Pharmaceutical Holdings Group Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5849-CPK-1002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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