At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Ketoprofen Lysine Salt combined with Gabapentin, Ketoprofen Lysine Salt, and 2 other interventions for No Condition. Completed, enrolled 141 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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
KLS (80 mg) alone in each treatment period in Part A and KLS alone (40 mg, 80 mg, or 160 mg) in Part B
300 mg
2 capsules to maintain the blind