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

NCT04312568 | Completed Phase 1

• 1 other identifier: 5849-CPK-1001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subject

Keywords

Healthy Subject; PK Study; Tolerability; Safety Evaluation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Fadanafil

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Fadanafil DRUG

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

Also known as: 5849

Fadanafil

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.: lead

Study Sites (1)

Haiyan Li

Beijing, Beijing Municipality, 100076, China

Location

MeSH Terms

Interventions

1,2-dibenzoyl-tert-butylhydrazine

Study Officials

• Haiyan Li, Doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 8 dose groups within 12.5mg\~500mg for single dose tolerability study to carrried out from low-dose group to high dose group

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 18, 2020
• Study Start: August 10, 2018
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

CN (1)