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

Phase 1

Completed

• Conditions: Healthy Subject
• Interventions: Drug: Fadanafil; Drug: Placebo

• Registration Number: NCT04312568
• Lead Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2018-08-10
• Primary Completion: 2018-12-07
• Study Completion: 2018-12-07
• Status Verified: 2020-03
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-16
• Last Update Submitted: 2020-03-16
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fadanafil	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
Placebo	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Haiyan Li; 🇨🇳 Beijing, Beijing, China