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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastroduodenal Erosions

Intervention / Treatment
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* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |