Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers

NCT02495831 | Completed Phase 1 Results

• 1 other identifier: Z7219J01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with respect to 50 mg diclofenac sodium administered alone.

Conditions

Healthy

Keywords

PK study

Outcome Measures

Primary Outcomes (1)

• To Evaluate Plasma Diclofenamic Acid Extent of Exposure Reported as Plasma AUC After Single Administration of 50 mg Diclofenac Sodium, With and Without Co-administration of a Single 200 mg Dose of Safinamide.

  Plasma diclofenamic acid AUC0-t after T2 single dose, with and without T1 co-administration. To measure AUC plasma samples were taken by the participants at different time points, and the concentrations of diclofenac and safinamide were measured. AUC0-t is the area under the concentration-time curve from administration to the last observed concentration time t; PK parameters AUC0-t were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.

  24 hours

Secondary Outcomes (4)

• Evaluate Diclofenac Rate of Absorption Reported as Plasma Cmax After Single Administration of 50 mg Diclofenac With and Without 200 mg of Safinamide.

  24 hours

• Tmax and T1/2

  24 hours

• Lamda z

  24 hours

• Relative Bioavailability (Frel)

  24 hours

Study Arms (2)

Diclofenac sodium

EXPERIMENTAL

Diclofenac sodium 50 mg oral tablets, single dose

Drug: Diclofenac sodium

Diclofenac sodium and safinamide

ACTIVE COMPARATOR

Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose

Drug: Diclofenac sodium and safinamide

Interventions

Diclofenac sodium DRUG

Diclofenac sodium 50 mg single dose

Also known as: Voltaren

Diclofenac sodium

Diclofenac sodium and safinamide DRUG

Diclofenac 50 mg single dose and safinamide 200 mg single dose

Also known as: Voltaren and Xadago

Diclofenac sodium and safinamide

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females, 25-55 years old
• Body Mass Index (BMI): 18.5-30 kg/m2
• Systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm
• Ability to comprehend the full nature and purpose of the study
• Females of child-bearing potential must use at least one of the following :
• A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit A male sexual partner who agreed to use a male condom with spermicide A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year were admitted.

You may not qualify if:

• Contraindications to MAO-B inhibitors, antiepileptic drugs, or to any NSAIDs
• Clinically significant abnormalities in ECG
• Clinically significant abnormal physical findings
• Clinically significant abnormal laboratory values
• Hypersensitivity or history of anaphylaxis to drugs or allergic reactions in general
• Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases
• Medications, including over the counter medications and herbal remedies, NSAID or anticoagulant use for 2 weeks before and during the entire study; morphine or other similar opioids, SSRIs, SNRIs, tri- or tetracyclic antidepressant, tramadol, pethidine, dextromethorphan, MAO inhibitors, meperidine derivatives and antiepileptic drugs, medicinal products that are BCRP substrates, any known enzyme inhibiting or inducing agent within 4 weeks preceding the screening visit.
• Participation in the evaluation of any investigational product for 3 months before the study.
• Blood donations for 3 months before the study
• History of drug, alcohol, caffeine or tobacco abuse
• Positive drug test at screening or day -1
• Positive alcohol breath test at day -1
• Abnormal diets or substantial changes in eating habits in the 4 weeks before the study; vegetarians
• Positive or missing pregnancy test at screening or day -1, pregnant or lactating women

Sponsors & Collaborators

• Zambon SpA: lead
• Cross Research S.A.: collaborator

Study Sites (1)

Cross Research SA, Phase I Unit

Arzo, Canton Ticino, 6864, Switzerland

Location

MeSH Terms

Interventions

Diclofenac; safinamide

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

no limitations

Results Point of Contact

• Title: Dr. Milko Radicioni
• Organization: CROSS REsearch SA

clinic@croalliance.com

+41.91.63.00

Study Officials

• Milko Radicioni, MD

  Cross Research SA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 13, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 15, 2016
• Results First Posted: April 15, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)