Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects

NCT ID: NCT02206854

Last Updated: 2015-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-09-30

Brief Summary

For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study R-flurbiprofen, will be available as gelatine capsules.

This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood samples at different time points. To assess the safety of the administered capsules adverse events will be documented.

Analysis of lipid signaling molecules in plasma will be done to assess the role of this molecules as variable for therapeutic effects.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

R-flurbiprofen

200 mg R-flurbiprofen in gelatine capsules once

Group Type: EXPERIMENTAL

R-flurbiprofen

Intervention Type: DRUG

200 mg gelatine capsule once orally

Interventions

R-flurbiprofen

200 mg gelatine capsule once orally

Intervention Type: DRUG

Other Intervention Names

Tarenflurbil

Eligibility Criteria

Inclusion Criteria

• Healthy subjects aged 18 to 65 years
• Body mass index (BMI) between 18.5 und 30 kg/m2
• Subject is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
• Subject has no evidence of clinically significant abnormality on echocardiogram (ECG) performed at screening visit and/or prior to administration of the study drug
• Non-Smoker
• Subjects providing informed consent

Exclusion Criteria

• Subjects with known hypersensitivity to study medication
• Subjects who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Subjects with a history of peptic ulcer disease and/or gastrointestinal bleeding
• Pregnant women (pregnancy rapid assay required for women with childbearing potential), women currently breast-feeding, or with the intention to breast-feed
• History or evidence of active malignancy within the 24 months prior to entry.
• Subject has a history of fainting during blood draws.
• Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 ml) in the last 4 weeks
• Subject is currently a regular user (including "recreational use) of illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years.
• Active or history of drug abuse,
• Chronic or acute renal, hepatic or metabolic disorder
• Participation in a clinical study within 30 days prior to screening
• Subjects with immunodeficiencies such as established acquired immunodeficiency syndrome.
• Subject is unable to refrain from or anticipates the use of any medication, (including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug until the follow-up visit.
• Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• There is any concern of the investigator regarding the safe participation of the subject in the study or for any other reason, the investigator considers the subject inappropriate for participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fraunhofer Institute for Translational Medicine and Pharmacology ITMP

OTHER

Sponsor Role: collaborator

Gerd Geisslinger

OTHER

Sponsor Role: lead

Responsible Party

Gerd Geisslinger

Professor Dr. Dr. Gerd Geisslinger

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gerd Geisslinger, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Locations

Johann Wolfgang Goethe University Hospital

Frankfurt, , Germany

Countries

Germany

Other Identifiers

2012-001425-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FLIP0112

Identifier Type: -

Identifier Source: org_study_id