Postherpetic Neuralgia Level: LLT Classification code 10036376
Conditions
Interventions
Product Name: N/A
Product Code: PNU-165442G
Pharmaceutical Form: Tablet
INN or Proposed INN: (+)-[S,S)]-Reboxetine
CAS Number: N/A
Current Sponsor code: N/A
Concentration unit: mg milligram(s)
Concent
Sponsors
Pfizer Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into thetrial: 1. Cohorts 1 and 2: Healthy male and/or female subjects between the ages of 18 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). 2. Cohort 3: Healthy male and/or female subjects aged 65 years (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). a) Female subjects must fulfill one of the following: b) Postmenopausal (two years since last period) subjects must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test immediately prior to commencing the study period. c) Surgically sterilized (tubal ligation). Subjects must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test immediately prior to commencing the study period. d) Surgically sterilized (hysterectomy). e) Females of child-bearing potential must be non-lactating and must have successfully practiced, over the last 3 months, one of the following contraceptive methods – oral, depot injection, intrauterine device or diaphragm plus spermicide, condoms, partner has had a vasectomy or abstention and must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test immediately prior to commencing the study period. g) All women of child-bearing potential have to use adequate contraceptive protection throughout the study period and for at least 1 full menstrual cycle after the follow-up visit. Women who have been surgically sterilized do not need to use birth control. 3. Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). 4. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. 5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: 1. Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). 2. Subjects with any condition possibly affecting drug absorption (eg, gastrectomy). 3. Subjects with a positive urine drug screen. 4. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. 5. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. 6. Treatment with an investigational drug within the past four months preceding the first dose of trial medication. 7. 12-lead ECG demonstrating QTc >430 msec (males) and QTc >450 msec (females) at screening. 8. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in Section 4.4.4 of the protocol from at least 14 days prior to the first dose of trial medication until completion of follow-up procedures. 9. Subjects who are taking, or have taken, any prescribed or over the counter drug (with the exception of paracetamol, up to 3g per day) in the three weeks prior to the first dose of study medication. Postmenopausal hormone replacement therapy (if stabilized on dose for at least 3 months) and hormonal contraception (if stabilized on a product and dose for at least 3 months) will be allowed. Subjects who are stabilized on certain chronically administered medications may be allowed provided the medications are not predicted to interact with (+)-[S,S]-RBX. 10. Administration of drugs and/or herbal preparations capable of inducing hepatic metabolism (eg barbiturates, rifampicin, carbamazepine, phenytoin, primidone or St John’s Wort) or monamine oxidase inhibitors (MAOIs) within 30 days (or 5 half-lives of the substance, whichever is longer) of enrollment in this study. 11. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing. 12. History of sensitivity to heparin or heparin-induced thrombocytopenia. 13. Subjects with a resting supine blood pressure below 100/55mmHg or who show a postural drop in either systolic or diastolic blood pressure of ³?20mmHg at screening. 14. Subjects unwilling or unable to comply with the Lifestyle guidelines presented in Section 4.4. of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and toleration of multiple oral doses of (+)-[S,S]-RBX administeredonce daily in an extended release formulation in young and elderly volunteers. To investigate the steady state pharmacokinetics of multiple oral doses of (+)-[S,S]-RBXadministered once daily in an extended release formulation in young and elderly volunteers.;Secondary Objective: None;Primary end point(s): Primary Endpoints: Safety and toleration of (+)-[S,S]-RBX; adverse event reporting, laboratorysafety tests, 12-lead ECG’s, vital signs and physical examination. Pharmacokinetic Endpoints: Pharmacokinetic profiles; plasma concentrations of (+)-[S,S]-RBXwill be measured on Day 10 (young) and 15 (elderly) to determine the multiple dose pharmacokinetics of (+)-[S,S]-RBX. Pharmacokinetic parameters: Cmax, tmax, Cmin, AUC0-t Cav, peak to trough ratio and peak to trough fluctuation. | — |
Countries
United Kingdom
Outcome results
None listed