Phase 1
Completed N=23
Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT02495831 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: 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. — 1323.28; 1381.32 h X ng per mL — p=0.1
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
1323.28; 1381.32 | 0.1 |
| SECONDARY Evaluate Diclofenac Rate of Absorption Reported as Plasma Cmax After Single Administration of 50 mg Diclofenac With and Without 200 mg of Safinamide. |
766.59; 833.50 | — |
| SECONDARY Tmax and T1/2 |
0.88; 1.0; 1.24; 1.19 | — |
| SECONDARY Lamda z |
0.63; 0.63 | — |
| SECONDARY Relative Bioavailability (Frel) |
107.67; 109.61 | — |
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent before inclusion in the study
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02495831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.