Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil （XZP-5849）in Chinese Healthy Adult Male Subjects

The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil （XZP-5849）in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Drug: Fadanafil; Drug: Placebo

Detailed Description

XZP-5849 is a selective phosphodiesterase (PDE5) inhibitor. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study in approximately 66 Chinese healthy adult male subjects. The study consists of 8 cohorts (1 cohort per dose level). Each subject will participate in only one cohort.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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: 19.0~25.0 kg/m2, inclusive
• 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.

Exclusion Criteria:

• Subjects who have a history of clinical significanct 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 serious systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular diseases or mental disorders.
• Subjects who have used over-the-counter drugs, health products, herbal medicine or traditional Chinese medicine within 2 weeks before screening, or are taking foods that affect CYP3A4, such as grapefruit or drinks containing grapefruit (except those who occasionally take paracetamol, but the total maximum dose cannot exceed 1g, and the drug is not allowed to take orally within 48 hours before the first administration).
• Subjects who have 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fadanafil; 8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose	Drug: Fadanafil; Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose; Other Names: 5849
PLACEBO_COMPARATOR: Placebo; 8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose	Drug: Placebo; Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrocardiogram (ECG)	To evaluate subject ECG Changing information	Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing.
Pharmacokinetic Parameter AUC(0-24)	AUC(0-24) of Fadanafile is area under the curve	Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 4, 6,8,12, 24,36 hours after Dosing
Blood Pressure and Heart Rate	To evaluate subject Blood Pressure and Heart Rate Changing information	Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing

Collaborators and Investigators

• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
• Investigators: Principal Investigator: Haiyan Li, Doctor, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2018
• Primary Completion (ACTUAL): December 7, 2018
• Study Completion (ACTUAL): December 7, 2018

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (ACTUAL): March 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Tolerability; Healthy Subject; PK Study; Safety Evaluation
• Other Study ID Numbers: 5849-CPK-1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No