NCT04802967

A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males

A Phase I, Double-Blind, PK, Safety, Tolerability Study of KSL + KLS-GABA vs KLS Alone in Healthy Males (Part A) Followed by a Study to Investigate the PD of KLS and KLS + GABA in Healthy Males (Part B)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Part A The primary objective of this study is to determine the single dose pharmacokinetics (PK) of ketoprofen lysine salt combined with gabapentin (KLS-GABA \[80 mg-34 mg\]) compared to KLS alone (80 mg) in healthy male subjects. The secondary objective of this study is: • To determine the safety and tolerability of a single oral dose of KLS-GABA (80 mg-34 mg) compared to KLS alone (80 mg) in healthy male subjects. Part B The primary objective of this study is to determine the pharmacodynamic (PD) effects of KLS-GABA in the Intradermal (ID) capsaicin model in healthy male subjects. The secondary objectives of this study are: * To further investigate the safety, tolerability, and PK of single oral doses of KLS-GABA and KLS alone. * To investigate the possible relationship between plasma levels of drug and efficacy in pain reduction.

Detailed description

This is a Phase I, Double-Blind, Pharmacokinetic, Safety and Tolerability Study of Ketoprofen Lysine Salt Combined with Gabapentin (KLS-GABA) Compared to Ketoprofen Lysine Salt (KLS) Alone in Healthy Male Subjects (Part A) Followed by a Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Pharmacodynamic Effects of KLS, and KLS in Combination with Gabapentin (GABA), in Healthy Male Subjects Using the Intradermal (ID) Capsaicin Model (Part B). Part A is a randomized, double-blind, crossover group study to investigate the safety, tolerability, and PK profile of a single oral dose of KLS-GABA compared to KLS alone in healthy male subjects. It is planned to enroll 12 subjects. All subjects take part in 2 treatment periods, in which they are randomized to receive either a single dose of KLS-GABA (80 mg-34 mg) or a single dose of KLS (80 mg) alone in each treatment period. Subjects' participation in Part A lasts approximately 7 weeks and will consist of the following: * A screening visit (up to 28 days prior to Day 1 of Treatment Period 1), * Admission to the clinical research unit (CRU) on Day -1 prior to Treatment Period 1, * Treatment Period 1 (Day 1 to Day 3), * A washout period of a minimum of 7 days, * Admission to the CRU on Day -1 prior to Treatment Period 2, * Treatment Period 2 (Day 1 to Day 3), * A follow-up visit (5 to 7 days post-final dose following Treatment Period 2). Safety will is assessed through Adverse Events (AE) reporting, 12-lead ECGs, vital signs, physical examinations, and clinical laboratory examinations. Pharmacokinetics are assessed by blood sampling. Part A treatment lasts 2 days (Day 1 in Treatment Period 1; Day 1 in Treatment Period 2) Part B is a randomized, double-blind, placebo-controlled parallel-group study to investigate the PD effects, PK/PD correlation, safety, and tolerability of three single oral dose levels of KLS-GABA compared to KLS alone, 300 mg gabapentin and placebo in the ID capsaicin model in healthy male subjects. It is planned to enroll 128 subjects, randomized evenly to 8 possible treatments; subjects receive either KLS alone, KLS-GABA, 300 mg gabapentin or placebo. The planned treatments are: * KLS alone (40 mg, 80 mg, or 160 mg) * KLS-GABA (40 mg-17 mg, 80 mg-34 mg or 160 mg-68 mg) * Gabapentin (300 mg) * Placebo Subjects' participation in Part B lasts approximately 6 weeks and consists of the following: * A screening visit (up to 28 days prior to dosing) * An additional screening visit (at least 7 days prior to dosing) to determine the subject's response to capsaicin and to familiarise them in the pain measurements, * Admission to the CRU on Day -1, for collection of pain measurements and completion of the ID capsaicin model * A treatment period (morning of Day 1 until 12 hours postdose) * Discharge from the CRU 12 hours postdose * A follow-up visit (5 to 7 days postdose). Safety is assessed through AE reporting, 12-lead ECGs, vital signs, physical examinations, and clinical laboratory examinations. Pharmacokinetics are assessed by blood sampling. Pharmacodynamics are assessed using the ID capsaicin model and pain measurements. Part B treatment lasts 1 day (Day 1).

Conditions

• No Condition

Interventions

Type	Name	Description
DRUG	Ketoprofen Lysine Salt combined with Gabapentin	KLS-GABA (80 mg-34 mg) in Part A and KLS-GABA (40 mg-17 mg or 80 mg-34 mg or 160 mg-68 mg) in Part B
DRUG	Ketoprofen Lysine Salt	KLS (80 mg) alone in each treatment period in Part A and KLS alone (40 mg, 80 mg, or 160 mg) in Part B
DRUG	Gabapentin	300 mg
OTHER	Placebo	2 capsules to maintain the blind

Timeline

• Start date: 2021-02-08
• Primary completion: 2022-03-30
• Completion: 2022-04-25
• First posted: 2021-03-17
• Last updated: 2024-12-27
• Results posted: 2024-12-27

Locations

1 site across 1 country: United Kingdom