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.
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
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.
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.
Sequential
iN1011-N17 HCl Suspension (Part 1)
DrugDose: 100 mg b.i.d for 7 days (Multiple Ascending Dose)
iN1011-N17 HCl Capsule (Part 1)
DrugDose: 200, 400, 800 mg b.i.d for 7 days (Multiple Ascending Dose)
Placebo Capsule (Part 1)
DrugDose: b.i.d for 7 days
iN1011-N17 HCl Capsule (Part 2)
DrugDose: 400 mg QD
iN1011-N17 Mesylate Capsule (Part 2)
DrugDose: 400 mg QD
iN1011-N17 HCl Capsule (Part 3)
DrugDose: 400 mg b.i.d for 14 days
iN1011-N17 Mesylate Capsule (Part 3)
DrugDose: 400 mg b.i.d for 14 days
Placebo Capsule (Part 3)
DrugDose: b.i.d for 14 days
8
Treatment groupsSee each treatment group below.
Incidence, severity, and causality of AEs and serious AEs (SAEs)
Incidence of Physical examination abnormalities
Incidence of Vital signs abnormalities
Incidence of 12-lead ECG abnormalities
Maximum plasma concentration (Cmax)
Time to maximum plasma concentration (Tmax)
Terminal half-life (t1/2)
Area under the plasma concentration curve (AUC0-12, AUC0-t, AUCinf)
Daily pain intensity is assessed using the Daily Pain Score (DPS), which is an 11-point numeric scale ranging from 0, indicating 'no pain', to 10, indicating 'pain as bad as you can imagine'.
Part 3 PHN patients
Score of Short Form McGill Pain Questionnaire (SF-MPQ) (Consists of 11 items. Uses a 4-point numeric scale ranging from 0, indicating 'none', to 4, indicating 'severe'.)
Part 3 PHN patients
Score of Brief Pain Inventory Short Form (BPI-SF). (measures pain intensity, its effect on functionality and impact of pain. Uses a 11-point numeric scale ranging from 0, indicating 'no pain', to 10, indicating 'pain as bad as you can imagine'.)
Part 3 PHN patients
Change in DPS score from Baseline Days 4, 7, 10, 14 and 21, based on daily pain assessment.
Part 3 PHN patients
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