No ConditionPhase 1NCT04802967

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

A Phase 1 study testing Ketoprofen Lysine Salt combined with Gabapentin, Ketoprofen Lysine Salt and Gabapentin in people with No Condition, run by Dompé Farmaceutici S.p.A at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: No Condition
What is being tested?: Ketoprofen Lysine Salt combined with Gabapentin, Ketoprofen Lysine Salt and Gabapentin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 141 participants
Where: 1 siteUnited Kingdom
Study dates: 8 Feb 2021to 25 Apr 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Part A
Subjects meeting the following criteria will be included in the study:
Subject is male, of any ethnic origin.
Subject is aged between 18 to 55 years, inclusive.
Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive.
Subject is ≥50 kg.

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Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at Screening and Day -1 in each treatment period.
Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examinations, concomitant medication, vital signs, 12-lead ECG, and clinical laboratory evaluations.
Subjects must use a condom during the trial and for 3 months after their final dose of trial medication, if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly effective contraception (see Section 6.4.1) from dosing until 3 months following dosing.
Subject is either a non-smoker or does not smoke more than 5 cigarettes per day (or equivalent e-cigarette use).
Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Part B
Subjects meeting the following criteria will be included in the study:
Subject is male, with a skin type compatible with capsaicin measurements.
Subject is aged between 18 to 55 years, inclusive.
Subject has a BMI of 18 to 32 kg/m2, inclusive.
Subject is ≥50 kg.
Negative SARS-CoV-2 test at Screening and Day -1.
Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, and clinical laboratory evaluations.
Subject must be in good general health with a skin type compatible with the measures, and without significant skin allergies, pigmentary disorders, or any active dermatological conditions that might interfere with the conduct of the study.
Subjects must use a condom during the trial and for 3 months after their final dose of trial medication, if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly effective contraception (see Section 6.4.1) from dosing until 3 months following dosing.
Subjects must be able to tolerate the capsaicin injection at screening.
Demonstration of positive hyperalgesia as defined by an area of hyperalgesia ≥15 cm2 15 minutes after ID administration of 100 μg capsaicin at the additional screening visit at least 7 days prior to first dosing.
Subject is a either non-smoker or does not smoke more than 5 cigarettes per day (or equivalent e-cigarette use).
Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

Part A
Subjects with any of the following will be excluded from study participation:
Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during screening as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine/diabetic, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at screening. In case of uncertain or questionable results, tests performed during screening may be repeated once to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism and excretion (ADME) of the study drugs.
Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, safety of the subject as per the SmPC of KLS and gabapentin (Neurontin 300 mg hard capsules) or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.

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Subject has a history of neurological disorders which may impact the perception of pain or impairs the subject's ability to fully participate in the study.
Subject has a significant skin allergy, pigmentary disorder, or any active dermatological condition.
AST, ALT, gamma-glutamyl transferase (GGT) or total bilirubin levels above the ULN at screening. These laboratory evaluations may be repeated once at the discretion of the Investigator. If the repeat test is within the reference range, the subject may be included only if the Investigator considers that the previous finding will not introduce additional risk factors and will not interfere with interpretation of safety data.
Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti- HCV) or human immunodeficiency virus I and II antibodies (anti-HIV I/II) at screening.
Positive urine test for drugs of abuse or alcohol breath test at screening or Day -1 of each treatment period.
History of drug and/or alcohol abuse/dependence, or intake of >28 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before screening and each scheduled visit until discharge from the CRU. One unit is equivalent to a 285 mL glass of full strength beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.
Habitual and heavy consumption of caffeinated beverages (>8 cups of coffee or equivalent per day) at screening; and/or unable to refrain from use of (methyl) xanthine (e.g., coffee, tea, cola, chocolate) from 48 hours prior to dosing until discharge from the CRU.
The subject has participated in a clinical study and has received a medication or a new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to dosing of current study medication.
Use of any prescription or non-prescription medications, including herbal and nutritional supplements (including St. John's wort), or OTC medications (e.g., ibuprofen, aspirin) within 14 days of dosing and throughout the study. By exception, the subject may take acetaminophen (less or equal 2 g/day) for up to 48 hours prior to dosing. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise subject safety or interfere with study procedures or data interpretation.
History of severe adverse reactions or allergies, or history of an anaphylactic reaction to prescription medications, non-prescription medication, food, NSAIDs or gabapentin (non-active hay-fever is acceptable).
Consumption of any food or drinks containing cranberry, pomegranate, starfruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 14 days before admission to the CRU until the end of the study.
Strenuous exercise within 48 hours prior to each blood collection for clinical laboratory tests.
Donation of blood or plasma of >500 mL within 3 months prior to first dosing, or subject intends to donate blood during the study.
Male subject who will not abstain from sperm donation between dosing and 3 months after final dosing.
Any degree of previous or known hypersensitivity to the active substance or the excipients of the IMP.
Part B
Subjects with any of the following will be excluded from study participation:
Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during screening as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine/diabetic, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at screening. In case of uncertain or questionable results, tests performed during screening may be repeated once to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
Has a skin trauma, any active skin disorder, significant scarring, significant skin allergy, pigmentary disorder, active dermatological condition, skin disease or tattoos on either forearm, or a significant history of trauma or skin disease in either arm.
Subject has a known intolerance to capsaicin, hot peppers, or any excipient in the IMP.
Subject has active chronic pain condition(s) or a history of chronic pain conditions.
History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the ADME of the study drug.
Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, safety of the subject as per the SmPCs of KLS and gabapentin (Neurontin 300 mg hard capsules) or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
Subject has a history of neurological disorders which may impact the perception of pain or impairs the subject's ability to fully participate in the study.
AST, ALT, GGT or total bilirubin levels above the ULN at screening. These laboratory evaluations may be repeated once at the discretion of the Investigator. If the repeat test is within the reference range, the subject may be included only if the Investigator considers that the previous finding will not introduce additional risk factors and will not interfere with interpretation of safety data.
Positive test for HBsAg, anti-HCV or anti-HIV I/II at screening.
Positive urine test for drugs of abuse or alcohol breath test at screening.
History of drug and/or alcohol abuse/dependence, or intake of >28 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before Screening and each scheduled visit until discharge from the CRU. One unit is equivalent to a 285 mL glass of full strength beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.
Habitual and heavy consumption of caffeinated beverages (>8 cups of coffee or equivalent per day) at screening; and/or unable to refrain from use of (methyl) xanthine (e.g., coffee, tea, cola, chocolate) from 48 hours prior to dosing until discharge from the CRU.
The subject has participated in a clinical study and has received a medication or a new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to dosing of current study medication.
Use of any prescription or non-prescription medications, including herbal and nutritional supplements (including St. John's wort), or OTC medications (e.g., ibuprofen, aspirin) within 14 days of dosing and throughout the study. By exception, the subject may take acetaminophen (less or equal 2 g/day) for up to 48 hours prior to dosing. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise subject safety or interfere with study procedures or data interpretation.
History of severe adverse reactions or allergies, or history of an anaphylactic reaction to prescription medication, non-prescription medication, food, NSAIDs, gabapentin, (non-active hay-fever is acceptable), the planned local anaesthesia/analgesic regimens, ethylenediaminetetraacetic acid, Kolliphor HS 15, butylated hydroxytoluene, or capsaicin.
Known hypersensitivity or allergy to any component of the placebo capsules.
Consumption of any food or drinks containing cranberry, pomegranate, starfruit, grapefruit, pomelos, exotic citrus fruits, or Seville oranges (including marmalade and juices made from these fruits) within 14 days before admission to the CRU until the end of the study.
Strenuous exercise within 48 hours prior to each blood collection for clinical laboratory tests.
Subject has participated in a clinical study involving administration of capsaicin within 12 months of the screening visit.
Donation of blood or plasma of >500 mL within 3 months prior to dosing, or subject intends to donate blood during the study.
Male subject who will not abstain from sperm donation between dosing and 3 months after dosing.
Any degree of previous or known hypersensitivity to the active substance or the excipients of the IMP.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

MAC Clinical Research Early Phase Unit
Manchester, M13 9NQ

Other trials in United Kingdom

About this study

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)

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.

Read the 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
Being tested: Ketoprofen Lysine Salt combined with Gabapentin, Ketoprofen Lysine Salt, Gabapentin, Placebo
Keywords: Male healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketoprofen Lysine Salt combined with GabapentinDrug
Also called KLS-GABA
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
Ketoprofen Lysine SaltDrug
Also called KLS
KLS (80 mg) alone in each treatment period in Part A and KLS alone (40 mg, 80 mg, or 160 mg) in Part B
GabapentinDrug
Also called GABA
300 mg
PlaceboOther
2 capsules to maintain the blind

Study groups in NCT04802967
Study group	Role	What they receive
KLS-GABA (part A and B)	Experimental	KLS-GABA 80 mg-34 mg capsules are administered once in the morning of Day 1 in Part A in Treatment Periods 1 and 2 in the fasted state, according to the randomisation schedule. Capsules are administered with 240 mL of water. KLS-GABA (40 mg-17mg, 80 mg-34 mg, or 160 mg-68 mg) in Part B are administered as capsules once in the morning of Day 1 in the fasted state. Capsules are administered with 240 mL of water. To maintain he blind, subjects assigned to receive 160 mg-68 mg KLS-GABA are administered two co-crystal KLS-GABA 114 mg (80 mg-34 mg) capsules, and subject assigned to receive 40 mg-17 mg KLS-GABA or 80 mg-34 mg KLS-GABA also receive a placebo capsule (dummy placebo). Receives: Drug: Ketoprofen Lysine Salt combined with Gabapentin
KLS (part A and B)	Active comparator	KLS 80 mg capsules are administered once in the morning of Day 1 in Part A in Treatment Periods 1 and 2 in the fasted state, according to the randomisation schedule. Capsules will be administered with 240 mL of water. In the part B KLS (40 mg, 80 mg or 160 mg) are administered as capsules once in the morning of Day 1 in the fasted state. Capsules are administered with 240 mL of water. To maintain the blind, subjects assigned to receive 160 mg KLS alone are administered two KLS 80 mg capsules and subjects assigned to receive either 40 mg KLS alone or 80 mg KLS alone also receive a placebo capsule (dummy placebo). Receives: Drug: Ketoprofen Lysine Salt
Gabapentin (part B)	Active comparator	Gabapentin 300 mg are administered as capsules once in the morning of Day 1 in the fasted state. Capsules are administered with 240 mL of water.To maintain the blind, subjects assigned to receive 300 mg gabapentin also receive a placebo capsule (dummy placebo). Receives: Drug: Gabapentin
Placebo (part B)	Placebo comparator	To maintain the blind subjects assigned to receive placebo receive 2 placebo capsules. Capsules will be administered with 240 mL of water. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Area Under the Concentration-time Curve (AUC) From Zero to the Last Quantifiable Concentrations (AUC0-t),
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.
Outcome measure at 0h,16h,24h,36h, and 48h postdose below limit of quantification (0.04 μg/mL).
The area under the concentration versus time curve from time zero to the last quantifiable concentration (C-last), calculated by the linear up-log down trapezoidal method; i.e. when concentrations are increasing (as in the absorption phase), the linear trapezoidal method is used, when concentrations are decreasing (as in the elimination phase), the logarithmic trapezoidal method is used.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Plasma PK Concentrations and Parameters of Ketoprofen (Part A):AUC From Zero to 12 Hours Postdose (AUC0-12h)
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.
The area under the concentration versus time curve from time zero to 12 h post-dose, calculated by the linear up-log down trapezoidal method.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): AUC From Zero to 24 Hours Postdose (AUC0-24h)
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.
The area under the concentration versus time curve from time zero to 24 h post-dose, calculated by the linear up-log down trapezoidal method.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Plasma PK Concentrations and Parameters of Ketoprofen (Part A):AUC From Zero to 36 Hours Postdose (AUC0-36h)
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.The area under the concentration versus time curve from time zero to 36 h post-dose, calculated by the linear up-log down trapezoidal method.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): AUC From Zero to 48 Hours Postdose (AUC0-48h)
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.The area under the concentration versus time curve from time zero to 48 h post-dose, calculated by the linear up-log down trapezoidal method.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Maximum Plasma Concentration (Cmax)
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.
Is defined Cmax the maximum observed concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Time to Maximum Plasma Concentration (Tmax)
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.
Is defined T max the time at which Cmax was apparent.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Half-life (t1/2)
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.
Is defined T1/2 The apparent terminal half-life, calculated from Log e 2 / z.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Change From Baseline in Area of Hyperalgesia (cm^2) Post-capsaicin Injection by MMRM Analysis. (Part B)
The area of mechanical hyperalgesia was assessed using a standard 24 g von Frey hair. The von Frey hair was applied at 1-second intervals along each of the 4 lines intersecting at the injection site drawn onto the skin before the injection. Stimulation began distal from the injection site and advanced in 1 cm increments toward the injection site until a pain response was elicited. Subjects were asked to report when the von Frey hair first began to cause any pain sensation or discomfort and the distance of that point from the injection site in centimetres for each line at each timepoint was recorded.
Measured: Day 1 at 15, 30, 60, 90 and 120 minutes post injection
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): AUC From Zero to Infinity (AUC0-∞),
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.
AUC0-∞ - area under the concentration versus time curve from time zero to infinity The area under the concentration-time curve estimated from time zero to infinity as the sum of the two areas: AUC0-t and AUCextrap, where AUCextrap is calculated as Ct / z. Estimates will be considered to be unreliable if the extrapolated area (AUCextrap) is >20%.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

Secondary outcomes (8)

Adverse Events (Part A)
An AE is any untoward medical occurrence in a study subject which either emerges or worsens from screening, during the clinical study, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavourable or unintended sign, including a clinically-significant abnormal laboratory finding, symptom, or disease temporally associated with the use of a medical product, whether or not it is considered to be study medication related.
Data define number of AE reported; frequency for each AE not being reported. Please note: these data in the CSR, as per study crossover design, are provided "per sequence" and not "per intervention". Hence, their representation "per intervention" it's not applicable.
Measured: Through part A, from screening day up to 5 to 7 days post final dose, i.e. up to 7 weeks
Subjective Rating of Pain From the ID Capsaicin Model (Part B)
Measurement of Pain Score (mm) Over Time. Pain is assessed through a visual analogue scale (VAS) consisting of a 100 mm line, with 0 representing "no pain'' and 100 "worst pain imaginable." Subjects are asked to mark the VAS using a single vertical stroke at the point they consider to appropriately reflect their level of pain from the injection of capsaicin (not general pain).
Measured: Prior to (within 15 minutes) and at the 15-, 30-, 60-, 90- and 120-minutes post-injection.
Change From Baseline of Pain Score of Hyperalgesia (NRS) by MMRM Analysis.(Part B)
Pain reduction/analgesia is measured through visual analogue scale (VAS) consisting of a 100 mm line, with 0 representing "no pain'' and 100 "worst pain imaginable." Subjects are asked to mark the VAS using a single vertical stroke at the point they consider to appropriately reflect their level of pain from the injection of capsaicin (not general pain). A new VAS are provided for each time-point and subjects are not allowed to see their previous VAS responses. The VAS is scored by measuring from the left-hand end of the scale to the point where the subject has marked the line, and the distance in mm recorded.
Measured: Day 1 at 15, 30, 60, 90 and 120 minutes post injection
Change From Baseline of Area of Brush-evoked Allodynia From the ID Capsaicin Model (Part B)
This outcome is assessed by sweeping a standard paintbrush at 1-second intervals across each of the 4 lines intersecting at the injection site drawn onto the skin before the injection. Stimulation begins distal from the injection site and advances in 1 cm increments toward the injection site until a pain response is elicited. Subjects are asked to indicate when the brush first begins to cause any pain or discomfort and the distance of that point from the injection site in centimetres for each line at each time-point is recorded. The area of allodynia was then calculated
Measured: Prior to (within 15 minutes) and at the 15-, 30-, 60-, 90- and 120-minutes post-injection.
Change From Baseline in Pain Score of Brush-evoked Allodynia From the ID Capsaicin Model (Part B)
Change from Baseline of Pain in response to brush stimulation of the allodynic area is recorded using an 11-point NRS ranging from 0 ("no pain") to 10 ("worst possible pain"). The pain score reflects the maximum pain experienced during the assessment.
Measured: Prior to (within 15 minutes) and at the 15-, 30-, 60-, 90- and 120-minutes post-injection.
Change From Baseline in Area of Flare (AF) From the ID Capsaicin Model (Part B)
The AF is determined by tracing the outline of visible skin reddening on to a sheet of acetate placed on the skin using a fine-tipped, permanent marker. The area is subsequently measured using planimetry and the results recorded in the CRF.
Measured: Day 1 Pre-Capsaicin Injection and at 15, 30, 60, 90 and 120 minutes post injection
Plasma PK Concentrations (Part B)
Plasma concentration levels of ketoprofen and gabapentin in Part B of the study are summarised by timepoint.
Measured: At Day 1 predose, pre-capsaicin and 2 hours post capsaicin
Adverse Events (Part B)
An AE is any untoward medical occurrence in a study subject which either emerges, or worsens from Screening, during the clinical study, regardless of its potential relationship to the medicinal product. An AE, therefore, can be any unfavourable or unintended sign, including a clinically-significant abnormal laboratory finding, symptom, or disease temporally associated with the use of a medical product, whether or not it is considered to be study medication related. Adverse events may include pre- or post-treatment events that occur as a result of Protocol- mandated procedures (i.e., invasive procedures, modification of subject's previous therapeutic regimen).
Data define number of AE reported; frequency for each AE not being reported.
Measured: The specific period of time over which adverse events data were collected was from screening day up to 5 to 7 days post final dose, i.e. up to 6 weeks for Part B

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 202125 Apr 2022

First posted17 Mar 2021
Study start8 Feb 2021
Primary completion30 Mar 2022
Study completion25 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for No ConditionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: In the Part B of the study the Intradermal (ID) Capsaicin Model is used.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04802967
Sponsor's protocol ID: KLG0120
Other IDs: 2020-004212-10
Status last verified: Dec 2024
First submitted: 12 Mar 2021
Last updated: 27 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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Questions to ask the study team

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Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04802967
Acronym / sponsor ID: KLG0120
Conditions: No Condition
Keywords: Male healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
Study start: 8 Feb 2021 (actual)
Primary completion: 30 Mar 2022 (actual)
Study completion: 25 Apr 2022 (actual)
First posted: 17 Mar 2021 (actual)
Results: Posted 27 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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)

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: In the Part B of the study the Intradermal (ID) Capsaicin Model is used.

Arm	Type	Receives
KLS-GABA (part A and B)	Experimental	Drug: Ketoprofen Lysine Salt combined with GabapentinKLS-GABA 80 mg-34 mg capsules are administered once in the morning of Day 1 in Part A in Treatment Periods 1 and 2 in the fasted state, according to the randomisation schedule. Capsules are administered with 240 mL of water. KLS-GABA (40 mg-17mg, 80 mg-34 mg, or 160 mg-68 mg) in Part B are administered as capsules once in the morning of Day 1 in the fasted state. Capsules are administered with 240 mL of water. To maintain he blind, subjects assigned to receive 160 mg-68 mg KLS-GABA are administered two co-crystal KLS-GABA 114 mg (80 mg-34 mg) capsules, and subject assigned to receive 40 mg-17 mg KLS-GABA or 80 mg-34 mg KLS-GABA also receive a placebo capsule (dummy placebo).
KLS (part A and B)	Active comparator	Drug: Ketoprofen Lysine SaltKLS 80 mg capsules are administered once in the morning of Day 1 in Part A in Treatment Periods 1 and 2 in the fasted state, according to the randomisation schedule. Capsules will be administered with 240 mL of water. In the part B KLS (40 mg, 80 mg or 160 mg) are administered as capsules once in the morning of Day 1 in the fasted state. Capsules are administered with 240 mL of water. To maintain the blind, subjects assigned to receive 160 mg KLS alone are administered two KLS 80 mg capsules and subjects assigned to receive either 40 mg KLS alone or 80 mg KLS alone also receive a placebo capsule (dummy placebo).
Gabapentin (part B)	Active comparator	Drug: GabapentinGabapentin 300 mg are administered as capsules once in the morning of Day 1 in the fasted state. Capsules are administered with 240 mL of water.To maintain the blind, subjects assigned to receive 300 mg gabapentin also receive a placebo capsule (dummy placebo).
Placebo (part B)	Placebo comparator	Other: PlaceboTo maintain the blind subjects assigned to receive placebo receive 2 placebo capsules. Capsules will be administered with 240 mL of water.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (25 listed)

Part A
Subject is male, of any ethnic origin.
Subject is aged between 18 to 55 years, inclusive.
Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive.
Subject is ≥50 kg.

Key exclusion criteria (46 listed)

Part A
Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during screening as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine/diabetic, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at screening. In case of uncertain or questionable results, tests performed during screening may be repeated once to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism and excretion (ADME) of the study drugs.
Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, safety of the subject as per the SmPC of KLS and gabapentin (Neurontin 300 mg hard capsules) or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ketoprofen Lysine Salt combined with GabapentinAlso: KLS-GABAKLS-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	KLS-GABA (part A and B)
Ketoprofen Lysine SaltAlso: KLSKLS (80 mg) alone in each treatment period in Part A and KLS alone (40 mg, 80 mg, or 160 mg) in Part B	Drug	KLS (part A and B)
GabapentinAlso: GABA300 mg	Drug	Gabapentin (part B)
Placebo2 capsules to maintain the blind	Other	Placebo (part B)

Primary outcome

Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Area Under the Concentration-time Curve (AUC) From Zero to the Last Quantifiable Concentrations (AUC0-t),
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed. Outcome measure at 0h,16h,24h,36h, and 48h postdose below limit of quantification (0.04 μg/mL). The area under the concentration versus time curve from time zero to the last quantifiable concentration (C-last), calculated by the linear up-log down trapezoidal method; i.e. when concentrations are increasing (as in the absorption phase), the linear trapezoidal method is used, when concentrations are decreasing (as in the elimination phase), the logarithmic trapezoidal method is used.
Plasma PK Concentrations and Parameters of Ketoprofen (Part A):AUC From Zero to 12 Hours Postdose (AUC0-12h)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed. The area under the concentration versus time curve from time zero to 12 h post-dose, calculated by the linear up-log down trapezoidal method.
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): AUC From Zero to 24 Hours Postdose (AUC0-24h)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed. The area under the concentration versus time curve from time zero to 24 h post-dose, calculated by the linear up-log down trapezoidal method.
Plasma PK Concentrations and Parameters of Ketoprofen (Part A):AUC From Zero to 36 Hours Postdose (AUC0-36h)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.The area under the concentration versus time curve from time zero to 36 h post-dose, calculated by the linear up-log down trapezoidal method.
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): AUC From Zero to 48 Hours Postdose (AUC0-48h)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed.The area under the concentration versus time curve from time zero to 48 h post-dose, calculated by the linear up-log down trapezoidal method.
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Maximum Plasma Concentration (Cmax)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed. Is defined Cmax the maximum observed concentration.
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Time to Maximum Plasma Concentration (Tmax)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed. Is defined T max the time at which Cmax was apparent.
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Half-life (t1/2)
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed. Is defined T1/2 The apparent terminal half-life, calculated from Log e 2 / z.
Change From Baseline in Area of Hyperalgesia (cm^2) Post-capsaicin Injection by MMRM Analysis. (Part B)
Time frame: Day 1 at 15, 30, 60, 90 and 120 minutes post injection
The area of mechanical hyperalgesia was assessed using a standard 24 g von Frey hair. The von Frey hair was applied at 1-second intervals along each of the 4 lines intersecting at the injection site drawn onto the skin before the injection. Stimulation began distal from the injection site and advanced in 1 cm increments toward the injection site until a pain response was elicited. Subjects were asked to report when the von Frey hair first began to cause any pain sensation or discomfort and the distance of that point from the injection site in centimetres for each line at each timepoint was recorded.
Plasma PK Concentrations and Parameters of Ketoprofen (Part A): AUC From Zero to Infinity (AUC0-∞),
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
PK parameters of ketoprofen when administered alone and when administered in combination with gabapentin in healthy male subjects were assessed. AUC0-∞ - area under the concentration versus time curve from time zero to infinity The area under the concentration-time curve estimated from time zero to infinity as the sum of the two areas: AUC0-t and AUCextrap, where AUCextrap is calculated as Ct / z. Estimates will be considered to be unreliable if the extrapolated area (AUCextrap) is >20%.

8 secondary outcomes

Adverse Events (Part A)
Time frame: Through part A, from screening day up to 5 to 7 days post final dose, i.e. up to 7 weeks
Subjective Rating of Pain From the ID Capsaicin Model (Part B)
Time frame: Prior to (within 15 minutes) and at the 15-, 30-, 60-, 90- and 120-minutes post-injection.
Change From Baseline of Pain Score of Hyperalgesia (NRS) by MMRM Analysis.(Part B)
Time frame: Day 1 at 15, 30, 60, 90 and 120 minutes post injection
Change From Baseline of Area of Brush-evoked Allodynia From the ID Capsaicin Model (Part B)
Time frame: Prior to (within 15 minutes) and at the 15-, 30-, 60-, 90- and 120-minutes post-injection.
Change From Baseline in Pain Score of Brush-evoked Allodynia From the ID Capsaicin Model (Part B)
Time frame: Prior to (within 15 minutes) and at the 15-, 30-, 60-, 90- and 120-minutes post-injection.
Change From Baseline in Area of Flare (AF) From the ID Capsaicin Model (Part B)
Time frame: Day 1 Pre-Capsaicin Injection and at 15, 30, 60, 90 and 120 minutes post injection
Plasma PK Concentrations (Part B)
Time frame: At Day 1 predose, pre-capsaicin and 2 hours post capsaicin
Adverse Events (Part B)
Time frame: The specific period of time over which adverse events data were collected was from screening day up to 5 to 7 days post final dose, i.e. up to 6 weeks for Part B

Results and safety

Results posted to the registry on 27 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
"KLS 80 mg Alone, Then KLS 80 Mg and GABA 34 mg" (PART A)	6	6
"KLS 80 Mg and GABA 34 mg Then KLS 80 mg Alone" (PART A)	6	6
KLS 40 mg	0	0
KLS 80 mg	0	0
KLS 160 mg	0	0
KLS 40 Mg-GABA 17 mg	0	0
KLS 80 mg- GABA 34 mg	0	0
KLS 160 Mg-GABA 68 mg	0	0
Gabapentin 300 mg	0	0
Placebo	0	0

Primary outcome: Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Area Under the Concentration-time Curve (AUC) From Zero to the Last Quantifiable Concentrations (AUC0-t),

Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose. Mean (Standard Deviation). Unit: μg*h/mL

Measure	KLS 80 mg (Part A) n = 12	KLS 80 Mg-GABA 34 mg (Part A) n = 12
Value	10.5 (2.70)	11.1 (2.94)

Population analysed: PK Analysis Set: consisted of all subjects who received a dose of the IMP (KLS-GABA or KLS) and had evaluable PK data.

Primary outcome: Plasma PK Concentrations and Parameters of Ketoprofen (Part A):AUC From Zero to 12 Hours Postdose (AUC0-12h)

Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose. Mean (Standard Deviation). Unit: μg*h/mL

Measure	KLS 80 mg (Part A) n = 12	KLS 80 Mg-GABA 34 mg (Part A) n = 12
Value	10.3 (2.25)	11.0 (2.89)

Population analysed: PK Analysis Set: consisted of all subjects who received a dose of the IMP (KLS-GABA or KLS) and had evaluable PK data.

Primary outcome: Plasma PK Concentrations and Parameters of Ketoprofen (Part A): AUC From Zero to 24 Hours Postdose (AUC0-24h)

Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose. Mean (Standard Deviation). Unit: μg*h/mL

Measure	KLS 80 mg (Part A) n = 12	KLS 80 Mg-GABA 34 mg (Part A) n = 12
Value	10.5 (2.42)	11.2 (3.02)

Population analysed: PK Analysis Set: consisted of all subjects who received a dose of the IMP (KLS-GABA or KLS) and had evaluable PK data.

Primary outcome: Plasma PK Concentrations and Parameters of Ketoprofen (Part A):AUC From Zero to 36 Hours Postdose (AUC0-36h)

Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose. Mean (Standard Deviation). Unit: μg*h/mL

Measure	KLS 80 mg (Part A) n = 12	KLS 80 Mg-GABA 34 mg (Part A) n = 12
Value	10.5 (2.56)	11.2 (3.00)

Population analysed: PK Analysis Set: consisted of all subjects who received a dose of the IMP (KLS-GABA or KLS) and had evaluable PK data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: The specific period of time over which adverse events data were collected was from screening day up to 5 to 7 days post final dose, *up to 7 weeks for Part A* and *up to 6 weeks for Part B*". Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KLS 80 mg (PART A)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
KLS 80 Mg and GABA 34 mg (PART A)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
KLS 40 mg (Part B)	0 of 16 (0%)	6 of 16 (37.5%)	0 of 16
KLS 80 mg (Part B)	0 of 16 (0%)	3 of 16 (18.8%)	0 of 16
KLS 160 mg (Part B)	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16
KLS 40 Mg-GABA 17 mg (Part B)	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16
KLS 80 mg- GABA 34 mg (Part B)	0 of 16 (0%)	6 of 16 (37.5%)	0 of 16
KLS 160 Mg-GABA 68 mg (Part B)	0 of 16 (0%)	4 of 16 (25%)	0 of 16
Gabapentin 300 mg (Part B)	0 of 16 (0%)	5 of 16 (31.3%)	0 of 16
Placebo (Part B)	0 of 16 (0%)	6 of 16 (37.5%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pui Man Leung, BMChB, MRCP principal investigator

MAC Clinical Research Early Phase Unit

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma PK Concentrations and Parameters of Ketoprofen (Part A): Area Under the Concentration-time Curve (AUC) From Zero to the Last Quantifiable Concentrations (AUC0-t), (time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04802967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.