Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

Oxford Pharmascience

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Ibuprofen Lysine; Drug: Ibuprofen-LDH; Drug: Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT02974361

OAT-01

Details and patient eligibility

About

This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen.

This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively.

A total of 30 subjects will take part in the study; 10 per study part.

The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects
• BMI 18 - 30 kg/m2
• Willing and able to provide written informed consent

Exclusion criteria

• Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction
• Recent or concurrent use of prescription or non-prescription medications, other than contraceptives
• Allergy or sensitivity to NSAIDs

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 17 patient groups

Part A Ibuprofen control

Active Comparator group

Treatment:

Drug: Ibuprofen

Part A Ibuprofen-LDH

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part A Ibuprofen-LDH Excipient Combo 1

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part A Ibuprofen-LDH Excipient Combo 2

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part A Ibuprofen-LDH Excipient Combo 3

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part A Ibuprofen-LDH Excipient Combo 4

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part A Ibuprofen Lysine

Active Comparator group

Treatment:

Drug: Ibuprofen Lysine

Part B Ibuprofen

Active Comparator group

Treatment:

Drug: Ibuprofen

Part B Ibuprofen LDH Excipient Combo 1

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part B Ibuprofen LDH Excipient Combo 2

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part B Ibuprofen LDH Excipient Combo 3

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part B Ibuprofen LDH Excipient Combo 4

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part C Ibuprofen

Active Comparator group

Treatment:

Drug: Ibuprofen

Part C Ibuprofen LDH Excipient Combo 1

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part C Ibuprofen LDH Excipient Combo 2

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part C Ibuprofen LDH Excipient Combo 3

Experimental group

Treatment:

Drug: Ibuprofen-LDH

Part B Ibuprofen LDH Excipient Combo 5

Experimental group

Treatment:

Drug: Ibuprofen-LDH