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

Oxford Pharmascience

Status and phase: Completed; Phase 1

Conditions: Gastroduodenal Erosions

Treatments: Drug: Ibuprofen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02521207

OXP001-003

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 4 patient groups

Part 1 OXP001

Experimental group

Description:

OXP001 formulation containing 800mg ibuprofen single dose

Treatment:

Drug: Ibuprofen

Part 1 Ibuprofen control

Active Comparator group

Description:

Ibuprofen control 800mg single dose

Treatment:

Drug: Ibuprofen

Part 2 OXP001

Experimental group

Description:

OXP001 formulation containing 800mg ibuprofen three times per day

Treatment:

Drug: Ibuprofen

Part 2 Ibuprofen control

Experimental group

Description:

Ibuprofen control 800mg three times per day

Treatment:

Drug: Ibuprofen