Pilot Study of OXP001(2) and Brufen in Healthy Subjects

A Two-Part, Randomised, Open-Label, Evaluator-Blinded, Multiple-Dose, Phase I Pilot Study With OXP001 Ibuprofen 400 mg Tablets and Brufen® 400 mg Tablets to Assess the Comparative Bioavailability (Part 1) and Effects on Gastroduodenal Irritation (Part 2) in Healthy Human Subjects

The study will compare the study drug to an already marketed formulation of prescription strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.

The study will consist of 2 parts involving up to 54 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product. Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of 800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001 or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach irritation using endoscopy.

Study Overview

• Status: Completed
• Conditions: Gastroduodenal Erosions
• Intervention / Treatment: Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Notts
    • Nottingham, Notts, United Kingdom, NG11 6JS
      • Quotient Clinical LTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female subject
• Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum) (Part 2 only)
• H. pylori negative

Exclusion Criteria:

• Clinically significant abnormal laboratory parameters
• Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, GI or any other body system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 OXP001; OXP001 formulation containing 800mg ibuprofen single dose	Drug: Ibuprofen
Active Comparator: Part 1 Ibuprofen control; Ibuprofen control 800mg single dose	Drug: Ibuprofen
Experimental: Part 2 OXP001; OXP001 formulation containing 800mg ibuprofen three times per day	Drug: Ibuprofen
Experimental: Part 2 Ibuprofen control; Ibuprofen control 800mg three times per day	Drug: Ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Comparison of Peak Plasma Concentration (Cmax)	Part 1; Day 1 and Day 4
Part 2: Comparison of Average Lanza Score	Part 2; Day 8
Part 2: Comparison of Average Number of Erosions	Day 8
Part 1: Comparison of Area Under the Curve (AUC)	Part 1; Day 1 and Day 4

Collaborators and Investigators

• Sponsor: Oxford Pharmascience Ltd
• Collaborators: Quotient Clinical
• Investigators: Principal Investigator: Stuart Mair, Quotient Clinical LTD

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: OXP001-003