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

No Condition Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 randomised, 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 enrol 12 subjects. All subjects take part in 2 treatment periods, in which they are randomised 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 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 randomised, 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 enrol 128 subjects, randomised 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 participantion 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). ;

Related Conditions & MeSH terms

• No Condition

• NCT number: NCT04802967
• Study type: Interventional
• Source: Dompé Farmaceutici S.p.A
• Status: Completed
• Phase: Phase 1
• Start date: February 8, 2021
• Completion date: April 25, 2022