Post Herpetic NeuralgiaPhase 1NCT06218784
A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.
A Phase 1 study testing iN1011-N17 HCl Suspension (Part 1), iN1011-N17 HCl Capsule (Part 1) and iN1011-N17 HCl Capsule (Part 2) in people with Post Herpetic Neuralgia and Pain, run by iN Therapeutics Co., Ltd. at 1 site in Australia.
Trial summary
This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamic properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia patients, and to assess the relative… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Herpetic Neuralgia, Pain, Osteoarthritis
- What is being tested?
- iN1011-N17 HCl Suspension (Part 1), iN1011-N17 HCl Capsule (Part 1) and iN1011-N17 HCl Capsule (Part 2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Nov 2022to 29 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
- Healthy male and female adults, aged 18 to 55 years of age (inclusive) at the time of consent.
- Body mass index (BMI = body weight (kg)/[height (m)]2) between 18 kg/m2 and 32 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 45 kg (inclusive).
- Clinically acceptable pulse rate, RR, and tympanic body temperature (pulse rate between 45 and 100 beats per minute [bpm]; SBP between 90 and 140 mmHg; DBP between 50 and 90 mmHg; RR between 12 and 22 breaths/min; tympanic body temperature between 35.5°C and 37.7°C at Screening and Day -1). Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position
- For Healthy Volunteers and Post-Herpetic Neuralgia Patients
- Clinical laboratory values within normal range as specified by the testing laboratory at Screening and Day -1, unless deemed not clinically significant by the Investigator.
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- All participants (excluding those who are exclusively in same-sex relationships, who are postmenopausal or have an exclusive partner who is postmenopausal) must agree to use a highly effective method of contraception throughout the study and for at least 30 days for females or 90 days for males after the last dose of IP. Female participants must not be breastfeeding, lactating, or pregnant during the study period.
- Female participants are required to be on their chosen contraceptive for at least 7 days before dosing.
- Female participants, where their sole, male sexual partner is vasectomized, must provide a verbal confirmation of azoospermia (90 days following the procedure) which should be recorded in the source documents by the Investigator.
- The minimum timeframe for pre-dose vasectomy for male participants is ≥ 12 weeks, unless they are the sole sexual partner of a female participant as outlined above.
- Male participants who are sexually active must use a condom combined with use of a highly-effective method of contraception for the female partner (excluding those who have had a vasectomy or whose partner is postmenopausal). Confirmation of the female partner's contraceptive information must be provided verbally by the male participant and should be recorded in the source documents by the Investigator. The postmenopausal status of the female partner must be confirmed verbally by the male participant and should be recorded in the source documents by the Investigator.
- Cognitively capable of understanding the provided information and able to fully comply with protocol requirements.
- Written informed consent prior to the commencement of any study procedures.
- Willing and able to perform the necessary visits to the investigational site/institution.
- In good general health at the Investigator's discretion, with no significant medical history, and with no clinically significant abnormalities on physical examination at Screening and before the first dose of IP.
- Post-Herpetic Neuralgia Patients
- Male and female adults aged 50 to 75 years of age (inclusive) at the time of consent.
- Clinically acceptable blood pressure (BP), pulse rate, RR, and tympanic body temperature (SBP between 90 and 140 mmHg; DBP between 50 and 95 mmHg; pulse rate between 45 and 100 bpm; RR between 12 and 22 breaths/min; tympanic body temperature between 35.5°C and 37.7°C) at Screening and Day -1. Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position.
- BMI (body weight (kg)/[height (m)]2) between 18 kg/m2 and 40 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 45 kg (inclusive).
- A diagnosis of neuropathic pain of PHN is confirmed when the pain for >3 months after the herpes zoster rash is healed, with the pain area of a continuous area of affected rash.
- Douleur Neuropathique 4 (DN4) score ≥4 at Screening.
Who cannot join
- For Healthy Volunteers and Post-Herpetic Neuralgia Patients
- Presence or history of carcinoma, hepatic, renal, neurological, pulmonary (except for childhood asthma), endocrine, hematologic, cardiovascular, or genitourinary disease that, in the opinion of the Investigator, may affect the evaluation of the IP or place the participant at undue risk (except for conditions that are stable on medications).
- Presence of any underlying physical or psychiatric condition (except for conditions that are stable on medications) that, in the opinion of the Investigator, would undermine participant compliance to protocol requirements.
- Presence or history of gastrointestinal disease (e.g., peptic ulcer, gastritis, gastric cramp, gastroesophageal reflex disease, Crohn's disease) or history of gastrointestinal surgery (except simple appendectomy or herniorrhaphy) that may affect assessment of safety and PK characteristics of the IP.
- Presence or history of central nervous system disease that may affect assessment of safety and PK characteristics of the IP.
- Presence of herniated disc (inter-vertebral, cervical or both) or history of related disease that, in the opinion of the Investigator, may affect assessment of safety and PK characteristics of the IP.
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- History of hypersensitivity to iN1011-N17 or to any of its components.
- History of allergy or sensitivity to sulfonamides, hay fever, asthma, eczema, food allergies and/or allergies to other medications. Participants with asymptomatic, untreated, seasonal allergies at the time of dosing may be considered for inclusion on a case-by-case basis- PI and Sponsor approval must be obtained prior to randomization.
- Any abnormal 12-lead ECG findings at Screening and Day -1, deemed by the Investigator or designee to be clinically significant.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) at Screening.
- Positive urine drug screen test (including methamphetamines, opiates, cocaine, cannabinoids, phencyclidine, benzodiazepines, barbiturates, methadone, tricyclic antidepressants, and amphetamines) or alcohol breath test at Screening and Day -1. Repeated tests will be allowed at the discretion of the Investigator for suspected false positives.
- Any of the following laboratory abnormalities within 14 days of the first treatment day:
- Platelet count < 100,000 cells/mm3
- Total neutrophil count < 1500 cells/mm3
- Serum creatinine ≥ 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) > 3.0 x ULN
- Aspartate aminotransferase (AST) > 3.0 x ULN
- Alkaline phosphatase > 2.0 x ULN
- Bilirubin > 1.5 x ULN
- Temperature ≥ 38°C or any other evidence of an infection
- Use of any prescription drugs (except the ones mentioned in Section 7.4.1) within 14 days, and over the counter (OTC) medications, herbal remedies (including St John's Wort), dietary supplements or vitamins within 7 days, or five half-lives of the product, whichever is longer, before the first dose of IP and for the duration of the study without prior approval of the Investigator and the MM. This includes analgesics such as paracetamol and non-steroidal anti-inflammatories (for healthy volunteers only).
- The use of any IP or investigational medical device within 30 days prior to Screening, or five half-lives of the product, whichever is longer.
- Blood or plasma donation of more than 450 mL within 90 days before the first dose of IP and for the duration of the study. It is recommended that blood/plasma donations not be made for at least 30 days after study completion.
- History of alcoholism, substance or drug abuse-related disorders deemed significant by the Investigator (or designee) (i.e., participants consuming > 21 units of alcohol per week for males and > 14 units of alcohol per week for females in the 90 days prior to dosing will be excluded. One unit of alcohol equals ½ pint [285 mL] of beer or lager, 1 glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
- Use of more than 5 nicotine-based products (including smoking tobacco, smokeless tobacco, and nicotine patches) per week, within 90 days prior to Screening. Volunteers must have a negative urine cotinine test at both Screening and Day -1 and refrain from the use of any nicotine-based products for the duration of the study.
- Consumption of beverages or foods that contain grapefruit, star fruit, pomelos, or products containing these fruits, from 7 days, or from the time that is deemed significant by the Investigator, and products containing caffeine (e.g., coffee, green tea, black tea, and sodas) from 48 hours before the first dose of IP until discharge from the study unit (includes the period between Periods 1 and 2 in Part 2).
- Unwilling to refrain from strenuous exercise from 48 hours prior to admission to the investigational site/institution and for the duration of the study, where strenuous exercise is defined as that which requires significant effort, energy, or strength, such as lifting weights or running.
- Any other reason that, in the opinion of the Investigator, may affect assessment of safety, PK, or PD characteristics of the IP.
- Have previously completed or withdrawn from this study or any other study investigating iN1011-N17 or have previously received the IP (for healthy volunteers only).
- Received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days, or a registered vaccine within 14 days prior to the Day -1 (Baseline visit).
- Post-Herpetic Neuralgia Patients
- PI-NRS score of PHN-associated neuropathic pain over the last 24 hours at randomization of ≥9 or at least a daily pain score of ≥9 during the Washout Period.
- Previous use of neurolytic block (e.g. chemical neurolytic block using phenol or ethyl alcohol, or radiofrequency thermocoagulation) or neurosurgical therapy for current PHN.
- Other severe pain or the presence of other skin diseases or pain at the site of the rash at Screening or randomization unrelated to PHN, that may confound the assessment of PHN.
- Participants who are unable or unwilling to cease the use of all pain medications, prescription and otherwise, as of the first day of the study Washout Period and until after Day 14 of the study. This includes all lamotrigine, carbamazepine, oxcarbazepine, mexiletine, valproate, lidocaine, lacosamide, amitriptyline, topiramate, selegiline, rasagiline medications. This excludes the use of paracetamol provided that a participant is able and willing to utilize a maximum of 4 g of paracetamol per 24-hour period as of the first day of the study Washout Period and until after Day 14 of the study. Common and approved medications for PHN patients are permitted if part of a stable treatment regimen (please refer to Section 7.4.1 for a list of permitted medications).
- Participants who are unable or unwilling to cease the use of prohibited medication (in Section 7.4.1) during the whole study period. Have previously received the IP or any other investigational drug/device within 30 days or 5 half-lives, whichever is greater.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
CMAX Clinical Research
Adelaide, South Australia, 5000
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple-Ascending Dose Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Properties of iN1011-N17 After Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia Patients and to Assess the Relative Bioavailability of Mesylate vs Hydrochloride Salt Capsules in Healthy Volunteers
This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamic properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia patients, and to assess the relative bioavailability of Mesylate vs Hydrochloride salt capsules of iN1011-N17 in Healthy volunteers.
- Conditions
- Post Herpetic Neuralgia, Pain, Osteoarthritis, Neuropathic Pain, Chronic Pain, Dorsal Root Ganglion
- Being tested
- iN1011-N17 HCl Suspension (Part 1), iN1011-N17 HCl Capsule (Part 1), Placebo Capsule (Part 1), iN1011-N17 HCl Capsule (Part 2), iN1011-N17 Mesylate Capsule (Part 2)
- Keywords
- Nav 1.7, Nav 1.7 inhibitor, Postoperative pain, Chemotherapy-induced neuropathic pain, Pain, Neurological Pain, Sodium Channel, Action Potential, Voltage Gated Sodium Channel, DRG Voltage Gated Sodium Channel 1.7, Sodium Channel 1.7, Volatage Gated Sodium Channel 1.7
- Medical subject headings
- Neuralgia, Postherpetic, Pain, Osteoarthritis, Neuralgia, Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iN1011-N17 HCl Suspension (Part 1)Drug
Dose: 100 mg b.i.d for 7 days (Multiple Ascending Dose)
iN1011-N17 HCl Capsule (Part 1)Drug
Dose: 200, 400, 800 mg b.i.d for 7 days (Multiple Ascending Dose)
Placebo Capsule (Part 1)Drug
Dose: b.i.d for 7 days
iN1011-N17 HCl Capsule (Part 2)Drug
Dose: 400 mg QD
iN1011-N17 Mesylate Capsule (Part 2)Drug
Dose: 400 mg QD
iN1011-N17 HCl Capsule (Part 3)Drug
Dose: 400 mg b.i.d for 14 days
iN1011-N17 Mesylate Capsule (Part 3)Drug
Dose: 400 mg b.i.d for 14 days
Placebo Capsule (Part 3)Drug
Dose: b.i.d for 14 days
| Study group | Role | What they receive |
|---|---|---|
| iN1011-N17 HCl Suspension (Part 1) | Experimental | Oral, Preformulation Suspension, b.i.d, Multiple Ascending Dose (Day 1~ Day7)
Part 1:
Participants will receive either iN1011-N17 or placebo in a 3:1 ratio. From Day 1 to Day 6, participants will receive iN1011-N17 or placebo b.i.d in the morning and in the evening, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 7 in the morning. Receives: Drug: iN1011-N17 HCl Suspension (Part 1) |
| iN1011-N17 HCl Capsule (Part 1) | Experimental | Oral, Nano Suspension Powder Capsule, b.i.d, Multiple Ascending Dose (Day 1~ Day7)
Part 1:
Participants will receive either iN1011-N17 or placebo in a 3:1 ratio. From Day 1 to Day 6, participants will receive iN1011-N17 or placebo b.i.d in the morning and in the evening, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 7 in the morning. Receives: Drug: iN1011-N17 HCl Capsule (Part 1) |
| Placebo Capsule (Part 1) | Placebo comparator | Oral, Placebo capsule, b.i.d, Multiple Ascending Dose (Day 1~ Day7)
Part 1:
Participants will receive either iN1011-N17 or placebo in a 3:1 ratio. From Day 1 to Day 6, participants will receive iN1011-N17 or placebo b.i.d in the morning and in the evening, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 7 in the morning. Receives: Drug: Placebo Capsule (Part 1) |
| iN1011-N17 HCl Capsule (Part 2) | Experimental | Oral, Nano Suspension Powder Capsule, Single dose
Part 2:
2-period, randomized, open-label, crossover bioavailability part. Participants will receive a single oral dose of each study treatment (HCl salt and Mesylate salt), one during each of the 2 inpatient periods, in a randomized sequence of administration. There will be a minimum washout period of 5 days between each dose of study treatment. Receives: Drug: iN1011-N17 HCl Capsule (Part 2) |
| iN1011-N17 Mesylate Capsule (Part 2) | Active comparator | Oral, AA10 Capsule, Single dose
Part 2:
2-period, randomized, open-label, crossover bioavailability part. Participants will receive a single oral dose of each study treatment (HCl salt and Mesylate salt), one during each of the 2 inpatient periods, in a randomized sequence of administration. There will be a minimum washout period of 5 days between each dose of study treatment. Receives: Drug: iN1011-N17 Mesylate Capsule (Part 2) |
| iN1011-N17 HCl Capsule (Part 3) | Experimental | Oral, Nano Suspension Powder Capsule, b.i.d, Multiple dose (Day 1~ Day7)
Part 3:
2 cohorts with up to 8 healthy volunteers and 8 PHN patients who will be randomized in a ratio of 3:1 to receive iN1011-N17 or placebo.
Each participant in both cohorts will receive oral doses of iN1011-N17/ placebo b.i.d from Day 1 to Day 13, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 14 in the morning. Receives: Drug: iN1011-N17 HCl Capsule (Part 3) |
| iN1011-N17 Mesylate Capsule (Part 3) | Placebo comparator | Oral, AA10 Capsule, b.i.d, Multiple dose (Day 1~ Day14)
Part 3:
2 cohorts with up to 8 healthy volunteers and 8 PHN patients who will be randomized in a ratio of 3:1 to receive iN1011-N17 or placebo.
Each participant in both cohorts will receive oral doses of iN1011-N17/ placebo b.i.d from Day 1 to Day 13, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 14 in the morning. Receives: Drug: iN1011-N17 Mesylate Capsule (Part 3) |
| Placebo Capsule (Part 3) | Experimental | Oral, Placebo capsule, b.i.d, Multiple dose (Day 1~ Day14)
Part 3:
2 cohorts with up to 8 healthy volunteers and 8 PHN patients who will be randomized in a ratio of 3:1 to receive iN1011-N17 or placebo.
Each participant in both cohorts will receive oral doses of iN1011-N17/ placebo b.i.d from Day 1 to Day 13, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 14 in the morning. Receives: Drug: Placebo Capsule (Part 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and causality of AEs and serious AEs (SAEs)
Measured: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of Physical examination abnormalities
Measured: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of Vital signs abnormalities
Measured: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of 12-lead ECG abnormalities
Measured: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of Continous cardiac telemetry abnormalities
Measured: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of Laboratory tests abnormalities
Measured: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Secondary outcomes (20)
Maximum plasma concentration (Cmax)
Measured: Part 1: Day 1 Part 2: 0-72 hours post dose Part 3: Day 1
Time to maximum plasma concentration (Tmax)
Measured: Part 1: Day 1 Part 2: 0-72 hours post dose Part 3: Day 1
Terminal half-life (t1/2)
Measured: Part 1: Day 1 Part 2: 0-72 hours post dose Part 3: Day 1
Area under the plasma concentration curve (AUC0-12, AUC0-t, AUCinf)
Measured: Part 1: Day 1 and Day 7 Part 2: 0-72 hours post dose Part 3: Day 1 and Day 14
Percentage of AUCinf based on extrapolation (AUC%extrap)
Measured: Part 1: Day 1 and Day 7 Part 2: 0-72 hours post dose Part 3: Day 1 and Day 14
Apparent volume of distribution (Vz/F)
Measured: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Apparent plasma elimination rate constant (λz)
Measured: Part 1: Day 1 and Day 7 Part 3: Day 1
Apparent clearance (CL/F)
Measured: Part 1: Day 1 Part 3: Day 1
Fraction excreted unchanged in urine (fe)
Measured: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Amount of drug excreted unchanged in the urine (Ae)
Measured: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Renal clearance (CLR)
Measured: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Mean residence time (MRT)
Measured: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Measured: Part 1: Day 7 Part 3: Day 14
Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss)
Measured: Part 1: Day 7 Part 3: Day 14
Average steady-state plasma drug concentration during multiple-dose administration (Cav,ss)
Measured: Part 1: Day 7 Part 3: Day 14
Time to reach maximum (peak) plasma concentration following drug administration at steady-state (Tmax,ss)
Measured: Part 1: Day 7 Part 3: Day 14
Area under the plasma concentration-time curve during a dosage interval (τ) (AUCτ)
Measured: Part 1: Day 7 Part 3: Day 14
Apparent clearance at steady state (CLss/F)
Measured: Part 1: Day 7 Part 3: Day 14
Apparent volume of distribution at steady state (Vz,ss/F)
Measured: Part 1: Day 7 Part 3: Day 14
Accumulation ratio of Cmax and AUC (RAcmax or RAAUC)
Measured: Part 1: Day 7 Part 3: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start11 Nov 2022
- Primary completion29 Jul 2024 (estimated)
- Study completion29 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Herpetic NeuralgiaStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iN Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218784
- Sponsor's protocol ID
- iN1011-N17102
- Status last verified
- Jun 2024
- First submitted
- 20 Dec 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple-Ascending Dose Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Properties of iN1011-N17 After Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia Patients and to Assess the Relative Bioavailability of Mesylate vs Hydrochloride Salt Capsules in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06218784
- Acronym / sponsor ID
- iN1011-N17102
- Conditions
- Post Herpetic Neuralgia, Pain, Osteoarthritis, Neuropathic Pain, Chronic Pain, Dorsal Root Ganglion
- Keywords
- Nav 1.7, Nav 1.7 inhibitor, Postoperative pain, Chemotherapy-induced neuropathic pain, Pain, Neurological Pain, Sodium Channel, Action Potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- iN Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 29 Jul 2024 (estimated)
- Study completion
- 29 Jul 2024 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamic properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia patients, and to assess the relative bioavailability of Mesylate vs Hydrochloride salt capsules of iN1011-N17 in Healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| iN1011-N17 HCl Suspension (Part 1) | Experimental | Drug: iN1011-N17 HCl Suspension (Part 1)Oral, Preformulation Suspension, b.i.d, Multiple Ascending Dose (Day 1~ Day7) Part 1: Participants will receive either iN1011-N17 or placebo in a 3:1 ratio. From Day 1 to Day 6, participants will receive iN1011-N17 or placebo b.i.d in the morning and in the evening, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 7 in the morning. |
| iN1011-N17 HCl Capsule (Part 1) | Experimental | Drug: iN1011-N17 HCl Capsule (Part 1)Oral, Nano Suspension Powder Capsule, b.i.d, Multiple Ascending Dose (Day 1~ Day7) Part 1: Participants will receive either iN1011-N17 or placebo in a 3:1 ratio. From Day 1 to Day 6, participants will receive iN1011-N17 or placebo b.i.d in the morning and in the evening, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 7 in the morning. |
| Placebo Capsule (Part 1) | Placebo comparator | Drug: Placebo Capsule (Part 1)Oral, Placebo capsule, b.i.d, Multiple Ascending Dose (Day 1~ Day7) Part 1: Participants will receive either iN1011-N17 or placebo in a 3:1 ratio. From Day 1 to Day 6, participants will receive iN1011-N17 or placebo b.i.d in the morning and in the evening, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 7 in the morning. |
| iN1011-N17 HCl Capsule (Part 2) | Experimental | Drug: iN1011-N17 HCl Capsule (Part 2)Oral, Nano Suspension Powder Capsule, Single dose Part 2: 2-period, randomized, open-label, crossover bioavailability part. Participants will receive a single oral dose of each study treatment (HCl salt and Mesylate salt), one during each of the 2 inpatient periods, in a randomized sequence of administration. There will be a minimum washout period of 5 days between each dose of study treatment. |
| iN1011-N17 Mesylate Capsule (Part 2) | Active comparator | Drug: iN1011-N17 Mesylate Capsule (Part 2)Oral, AA10 Capsule, Single dose Part 2: 2-period, randomized, open-label, crossover bioavailability part. Participants will receive a single oral dose of each study treatment (HCl salt and Mesylate salt), one during each of the 2 inpatient periods, in a randomized sequence of administration. There will be a minimum washout period of 5 days between each dose of study treatment. |
| iN1011-N17 HCl Capsule (Part 3) | Experimental | Drug: iN1011-N17 HCl Capsule (Part 3)Oral, Nano Suspension Powder Capsule, b.i.d, Multiple dose (Day 1~ Day7) Part 3: 2 cohorts with up to 8 healthy volunteers and 8 PHN patients who will be randomized in a ratio of 3:1 to receive iN1011-N17 or placebo. Each participant in both cohorts will receive oral doses of iN1011-N17/ placebo b.i.d from Day 1 to Day 13, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 14 in the morning. |
| iN1011-N17 Mesylate Capsule (Part 3) | Placebo comparator | Drug: iN1011-N17 Mesylate Capsule (Part 3)Oral, AA10 Capsule, b.i.d, Multiple dose (Day 1~ Day14) Part 3: 2 cohorts with up to 8 healthy volunteers and 8 PHN patients who will be randomized in a ratio of 3:1 to receive iN1011-N17 or placebo. Each participant in both cohorts will receive oral doses of iN1011-N17/ placebo b.i.d from Day 1 to Day 13, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 14 in the morning. |
| Placebo Capsule (Part 3) | Experimental | Drug: Placebo Capsule (Part 3)Oral, Placebo capsule, b.i.d, Multiple dose (Day 1~ Day14) Part 3: 2 cohorts with up to 8 healthy volunteers and 8 PHN patients who will be randomized in a ratio of 3:1 to receive iN1011-N17 or placebo. Each participant in both cohorts will receive oral doses of iN1011-N17/ placebo b.i.d from Day 1 to Day 13, with approximately 12 hours between the 2 daily doses, and receive the last dose on Day 14 in the morning. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Healthy Volunteers
- Healthy male and female adults, aged 18 to 55 years of age (inclusive) at the time of consent.
- Body mass index (BMI = body weight (kg)/[height (m)]2) between 18 kg/m2 and 32 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 45 kg (inclusive).
- Clinically acceptable pulse rate, RR, and tympanic body temperature (pulse rate between 45 and 100 beats per minute [bpm]; SBP between 90 and 140 mmHg; DBP between 50 and 90 mmHg; RR between 12 and 22 breaths/min; tympanic body temperature between 35.5°C and 37.7°C at Screening and Day -1). Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position
- For Healthy Volunteers and Post-Herpetic Neuralgia Patients
Key exclusion criteria (36 listed)
- For Healthy Volunteers and Post-Herpetic Neuralgia Patients
- Presence or history of carcinoma, hepatic, renal, neurological, pulmonary (except for childhood asthma), endocrine, hematologic, cardiovascular, or genitourinary disease that, in the opinion of the Investigator, may affect the evaluation of the IP or place the participant at undue risk (except for conditions that are stable on medications).
- Presence of any underlying physical or psychiatric condition (except for conditions that are stable on medications) that, in the opinion of the Investigator, would undermine participant compliance to protocol requirements.
- Presence or history of gastrointestinal disease (e.g., peptic ulcer, gastritis, gastric cramp, gastroesophageal reflex disease, Crohn's disease) or history of gastrointestinal surgery (except simple appendectomy or herniorrhaphy) that may affect assessment of safety and PK characteristics of the IP.
- Presence or history of central nervous system disease that may affect assessment of safety and PK characteristics of the IP.
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 |
|---|---|---|
| iN1011-N17 HCl Suspension (Part 1)Dose: 100 mg b.i.d for 7 days (Multiple Ascending Dose) | Drug | iN1011-N17 HCl Suspension (Part 1) |
| iN1011-N17 HCl Capsule (Part 1)Dose: 200, 400, 800 mg b.i.d for 7 days (Multiple Ascending Dose) | Drug | iN1011-N17 HCl Capsule (Part 1) |
| Placebo Capsule (Part 1)Dose: b.i.d for 7 days | Drug | Placebo Capsule (Part 1) |
| iN1011-N17 HCl Capsule (Part 2)Dose: 400 mg QD | Drug | iN1011-N17 HCl Capsule (Part 2) |
| iN1011-N17 Mesylate Capsule (Part 2)Dose: 400 mg QD | Drug | iN1011-N17 Mesylate Capsule (Part 2) |
| iN1011-N17 HCl Capsule (Part 3)Dose: 400 mg b.i.d for 14 days | Drug | iN1011-N17 HCl Capsule (Part 3) |
| iN1011-N17 Mesylate Capsule (Part 3)Dose: 400 mg b.i.d for 14 days | Drug | iN1011-N17 Mesylate Capsule (Part 3) |
| Placebo Capsule (Part 3)Dose: b.i.d for 14 days | Drug | Placebo Capsule (Part 3) |
Primary outcome
Incidence, severity, and causality of AEs and serious AEs (SAEs)
Time frame: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of Physical examination abnormalities
Time frame: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of Vital signs abnormalities
Time frame: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of 12-lead ECG abnormalities
Time frame: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of Continous cardiac telemetry abnormalities
Time frame: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
Incidence of Laboratory tests abnormalities
Time frame: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
20 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Part 1: Day 1 Part 2: 0-72 hours post dose Part 3: Day 1
Time to maximum plasma concentration (Tmax)
Time frame: Part 1: Day 1 Part 2: 0-72 hours post dose Part 3: Day 1
Terminal half-life (t1/2)
Time frame: Part 1: Day 1 Part 2: 0-72 hours post dose Part 3: Day 1
Area under the plasma concentration curve (AUC0-12, AUC0-t, AUCinf)
Time frame: Part 1: Day 1 and Day 7 Part 2: 0-72 hours post dose Part 3: Day 1 and Day 14
Percentage of AUCinf based on extrapolation (AUC%extrap)
Time frame: Part 1: Day 1 and Day 7 Part 2: 0-72 hours post dose Part 3: Day 1 and Day 14
Apparent volume of distribution (Vz/F)
Time frame: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Apparent plasma elimination rate constant (λz)
Time frame: Part 1: Day 1 and Day 7 Part 3: Day 1
Apparent clearance (CL/F)
Time frame: Part 1: Day 1 Part 3: Day 1
Fraction excreted unchanged in urine (fe)
Time frame: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Amount of drug excreted unchanged in the urine (Ae)
Time frame: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Renal clearance (CLR)
Time frame: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Mean residence time (MRT)
Time frame: Part 1: Day 1 and Day 7 Part 3: Day 1 and Day 14
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Time frame: Part 1: Day 7 Part 3: Day 14
Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss)
Time frame: Part 1: Day 7 Part 3: Day 14
Average steady-state plasma drug concentration during multiple-dose administration (Cav,ss)
Time frame: Part 1: Day 7 Part 3: Day 14
Time to reach maximum (peak) plasma concentration following drug administration at steady-state (Tmax,ss)
Time frame: Part 1: Day 7 Part 3: Day 14
Area under the plasma concentration-time curve during a dosage interval (τ) (AUCτ)
Time frame: Part 1: Day 7 Part 3: Day 14
Apparent clearance at steady state (CLss/F)
Time frame: Part 1: Day 7 Part 3: Day 14
Apparent volume of distribution at steady state (Vz,ss/F)
Time frame: Part 1: Day 7 Part 3: Day 14
Accumulation ratio of Cmax and AUC (RAcmax or RAAUC)
Time frame: Part 1: Day 7 Part 3: Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iN1011-N17 HCl Suspension (Part 1), iN1011-N17 HCl Capsule (Part 1) and iN1011-N17 HCl Capsule (Part 2) in people with Post Herpetic Neuralgia and Pain, run by iN Therapeutics Co., Ltd. at 1 site in Australia.
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 21 inclusion and 36 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: status not confirmed, as of the sponsor's last update on 24 Jun 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 Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeseul Shin (+82313328425, hangsu1208@intherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and causality of AEs and serious AEs (SAEs) (time frame: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2024.