Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04802967
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2021-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males
Sponsor:
Dompé Farmaceutici S.p.A
Organization:
Study Overview
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
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-004212-10 | EUDRACT_NUMBER | None | View |