A study to investigate the effects of two painkillers as a combination treatment for pai

Phase 1

• Conditions: ovel treatment combination for neuropathic pain in healthy male volunteers; Not Applicable

• Registration Number: ISRCTN30672343
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-01
• Last Update Posted: 19 April 2022
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Healthy subjects, 18 to 65 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg and a maximum weight of 100 kg.
3. Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria

1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
2. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
3. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
4. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at screening.
5. Abnormal findings in the resting ECG at screening defined as:
a. QTcF> 450 or < 300 msec for men and QTcF> 470 or < 300 msec for women
b. Notable resting bradycardia (HR < 45 bpm) or tachycardia (HR > 100 bpm)
c. Personal or family history of congenital long QT syndrome or sudden death;
d. ECG with QRS and/or T wave judged to be unfavourable for a consistently accurate QT measurement (e.g., neuromuscular artefact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves);
e. Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or cardiac pacemaker
6. Use of any medications (prescription or over-the-counter [OTC]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day) and ibuprofen (up to 1g/day), which are allowed up to 2 days before screening and 2 days before each study drug administration. Other exceptions will only be made if the rationale is clearly documented by the investigator.
7. Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is clearly documented by the investigator.
8. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study).
9. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units (for males) or 14 units (for females) of alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquilizers, or any other addictive agent
10. Positive test for drugs of abuse at screening or pre-dose.
11. Alcohol will not be allowed from at least 24 hours before screening or each admission.
12. Current use of tobacco or nicotine products and u

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Analgesic effects measured using the following pre-dose up to 9 h post-dose:<br> 1. Pressure Pain: Pain Detection Threshold (PDT), Pain Tolerance Threshold (PTT), Area Under the Curve (AUC), post-test Visual Analogue Scale (VAS)<br> 2. Heat pain (pre-cold pressor: unexposed/normal and UVB-exposed skin, the latter only for subjects with MED lower than 355 mJ/cm² at screening): PDT, and post-test VAS.<br> 3. Cold Pressor: PDT, PTT, Area Above the Curve (AAC), post-test VAS<br> 4. Electrical Stair test: PDT, PTT, AUC, post-test VAS<br> 5. Electrical burst test: PDT, PTT, AUC, post-test VAS<br> 6. Conditioned Pain Modulation (CPM) Response (change from heat pain pre-and post-cold pressor): PDT<br> 7. Short Form McGill Pain Questionnaire (SFMPQ) for pressure pain, heat pain, cold pressor, electrical stair test and electrical burst test.<br>