Phase I/II trial for safety and pharmacokinetics of ENDOPIN in healthy adults and patients with pain

JRCT ID: jRCT2051220144

Registered date:04/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Phase 1 part: Healthy adult male Phase 2 part: Postoperative pain patients
• Date of first enrollment: 04/01/2023
• Target sample size: 46
• Study type: Interventional
• Intervention(s): Test drug, ENDOPIN tablets, each tablet contains 5 mg of ENDOPIN and control drug, ENDOPIN placebo tablets, placebo containing only the base drug is randomly assigned.In Phase 1, patients will take one, two, four, or six ENDOPIN or ENDOPIN placebo tablets once. In Phase 2, patients will take ENDOPIN or ENDOPIN placebo tablets at the dose established in Phase 1.

Outcome(s)

• Primary Outcome: Safety (Phase 1 part, Phase 2 part)

Secondary Outcome

1) Plasma drug concentration (Phase 1 part, Phase 2 part)
2) Assessment of pain improvement by NRS and VAS (Phase 2 part)
3) Usage of rescue medication (Phase 2 part)
4) Evaluation of patient impressions (Phase 2 part)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Phase 1 Part
1) Male age between 18 and 40 years old at the time consent is obtained.
2) All of the following are met at the pre-enrollment examination
Hemoglobin level more than or equal to 10 g/dL
White blood cell count more than or equal to 3,000 /micro-L
Platelet count more than or equal to 100,000/micro-L
AST (GOT) less than or equal to 50 U/L
ALT (GPT) less than or equal to 50 U/L
Total bilirubin less than or equal to1.5 mg/dL
Serum creatinine less than or equal to 1.5 mg/dL
HbA1c (NGSP) less than 7.0 % (data within 56 days prior to enrollment are acceptable)
BMI more than or equal to 18.5 and less than 25.0
3) Non-smoker and no history of smoking in the past year
4) Written consent to participate in this study has been obtained from the individual.
Phase 2 Part
1) Patients must be at least 18 years of age at the time of consent.
2) Patients who have undergone thoracoscopic lobectomy or segmentectomy for primary lung cancer within 8 weeks of obtaining consent.
3) Patients must have the following on the most recent examination within 56 days prior to enrollment
HbA1c (NGSP value) less than 7.0 %.
4) For female patients, one of the following is met and there is no possibility of pregnancy
The patient has been considered menopausal for at least 12 months since her last menstrual period without another medical reason.
Has undergone permanent sterilization such as bilateral oophorectomy, bilateral tubal ligation, etc.
5) Written consent to participate in this study has been obtained from the patient.
6) The following criteria are met on the first day after surgery
6-1) All of the following are met at the pre-registration examination on the 1st day after surgery
Hemoglobin level more than or equal to 10 g/dL
White blood cell count more than or equal to 3,000 /micro-L
Platelet count more than or equal to 100,000 /micro-L
AST (GOT) less than or equal to 50 U/L
ALT (GPT) less than or equal to 50 U/L
Total bilirubin less than or equal to 1.5 mg/dL
Serum creatinine less than or equal to 1.5 mg/dL
6-2)Systemic antipyretic analgesics are not necessary for fever
6-3)NRS pain scale is more than ornequal to 4 and the patient can take loxoprofen sodium tablets 60 mg
6-4) No serious complications (pneumonia, respiratory failure, pulmonary thromboembolism, etc.) related to the surgery have developed.

Exclude criteria

Phase 1 Part
1) Patient has one of the following complications
Serious hepatic or renal disease
Cardiac dysfunction equivalent to NYHA II degree or higher
History of malignancy or liver disease requiring treatment
2) Positive infectious disease test at screening: HBs antigen/antibody, HBc antibody, HCV antibody, HIV antigen/antibody, syphilis, tuberculosis
3) Positive PCR test for novel coronavirus at the time of admission
4) Those diagnosed with infectious gastroenteritis within 7 days prior to enrollment (including family members living in the same household)
5) Has food allergy or drug hypersensitivity or has a history of such allergy or drug hypersensitivity.
6) Has alcohol or drug dependence or a history of alcohol or drug dependence.
7) Has used systemic drugs as a regular prescription within 4 weeks prior to obtaining consent.
8) Participates in another clinical study or trial involving an intervention within 4 months (same date 4 months prior) prior to obtaining consent.
9) Cannot agree to use contraception for a period of up to 7 days after administration of the investigational drug.
10) Uses oral medications other than investigational drugs and topical medications containing analgesic ingredients within 7 days prior to enrollment.
11) Has had blood drawn or donated more than 200 mL within 4 weeks or 400 mL within 12 weeks prior to administration of the investigational drug, and has donated component blood within 2 weeks prior to administration of the investigational drug.
12) Have previously received the investigational drug.
13) Other patients who, in the judgment of the investigator or subinvestigator, are inappropriate to participate in this clinical trial.
Phase 2 Part
1) One of the following complications
Serious liver or renal disease
Cardiac dysfunction equivalent to NYHA II degree or higher
Peptic ulcer, aspirin asthma, or a history of peptic ulcer
Disease with pain that may affect pain assessment
2) Use of analgesics (oral or topical) as a regular prescription within 4 weeks prior to obtaining consent.
3) Participating in another clinical study/trial involving intervention within 4 months (same date 4 months prior) prior to obtaining consent.
4) Has a history of hypersensitivity to loxoprofen sodium hydrate, acetaminophen and local anesthetics, clonidine hydrochloride tablets, guanabenz acetate tablets, methyldopa tablets, dexmedetomidine.
5) Has undergone another surgical procedure within 4 weeks prior to obtaining consent.
6) Unable to consent to smoking cessation up to 1 month prior to administration of the investigational drug (same date 1 month prior).
7) Male who cannot agree to use contraception up to 7 days after administration of the investigational drug.
8) Other subjects who, in the judgment of the investigator or subinvestigator, are considered inappropriate to participate in this clinical trial.

Related Information

• Primary Sponsor: Nakajima Takako