NCT01339156

Study of P3914 to Evaluate the Safety, Tolerability, Food Effect & Pharmacokinetics in Healthy Male Subjects and Efficacy & Safety of P3914 in Patients With Acute Dental Pain

Randomized, Double-blind, Placebo-controlled Phase I-Ib Study of P3914 to Evaluate the Safety, Tolerability, Food Effect & Pharmacokinetics in Healthy Male Subjects and Efficacy & Safety of P3914 in Patients With Acute Dental Pain

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Piramal Enterprises Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

P3914 a pro-drug of Naproxen, characterized by naproxen (COX inhibiting moiety) linked to a NO moiety is intended for the treatment of pain and inflammation. The rationale behind development of P3914 is to maintain the analgesic, antipyretic and anti-inflammatory activity of naproxen and enhance GI safety by virtue of release of NO besides with no major effect on blood pressure on long-term administration.

Conditions

• Acute Dental Pain

Interventions

Type	Name	Description
DRUG	P3914	Part A: The subjects will be fasted overnight for at least 10 hrs.The drug will be administered orally to each subject in sitting posture. Part B: Dosing will start on Day 1. Each subject will receive the investigational product under fasting conditions for 14 days (Days 1 to 14). The investigational product will be administered orally to each subject with 240 mL of water. Part C: Dosing will take place on Day 1 of each study period. Each subject will receive a single oral dose. For administration of P3914 tablets subjects will be required to fast for 10 hrs prior to dosing. Part D: Patients will be fasted for at least 4-6 hrs. The investigational product will be administered orally to each subject in sitting posture on day 1 within 6 hrs of first administration of anesthesia (day of dental surgery).
DRUG	Placebo	Part A: The subjects will be fasted overnight for at least 10 hrs. The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject in sitting posture. Part B: Dosing will start on Day 1. It is planned that each subject will receive the investigational product under fasting conditions for 14 days (Days 1 to 14). The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject with 240 mL of water. Part D: Patients will be fasted for at least 4-6 hrs. The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject in sitting posture on day 1 within 6 hrs of first administration of anesthesia (day of dental surgery).

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-11-01
• Completion: 2012-06-01
• First posted: 2011-04-20
• Last updated: 2012-11-22