First-in-Patient Study for Sing le Dose of M201-A Hydrochloride Injection in Japanese Patients With Paroxysmal Atrial Fibrillation

NCT ID: NCT04609059

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2020-12-31

Brief Summary

First-in-Patient Study for sing le dose of M201-A hydrochloride injection in Japanese patients with paroxysmal atrial fibrillation.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

M201-A Injection

Active Substance: M201-A Route of administration: continuous intravenous injection

Group Type: EXPERIMENTAL

M201-A Injection

Intervention Type: DRUG

Active Substance: M201-A Route of administration: continuous intravenous injection

Step 1: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.4 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes Step 2: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.6 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes (Based on recommendations of an independent data monitoring committee; data and safety monitoring board, it will be decided that dosage is 0.20 mg/kg or 0.40 mg/kg. If appropriate, Step 2 will not be conducted.)

Placebo

Saline Placebo for M201-A Route of administration: continuous intravenous injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Saline Placebo: M201-A Placebo Route of administration: continuous intravenous injection

Step 1: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.4 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes Step 2: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.6 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes (Based on recommendations of an independent data monitoring committee; data and safety monitoring board, it will be decided that dosage is 0.20 mg/kg or 0.40 mg/kg. If appropriate, Step 2 will not be conducted.)

Interventions

M201-A Injection

Active Substance: M201-A Route of administration: continuous intravenous injection

Step 1: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.4 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes Step 2: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.6 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes (Based on recommendations of an independent data monitoring committee; data and safety monitoring board, it will be decided that dosage is 0.20 mg/kg or 0.40 mg/kg. If appropriate, Step 2 will not be conducted.)

Intervention Type: DRUG

Placebo

Saline Placebo: M201-A Placebo Route of administration: continuous intravenous injection

Step 1: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.4 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes Step 2: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.6 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes (Based on recommendations of an independent data monitoring committee; data and safety monitoring board, it will be decided that dosage is 0.20 mg/kg or 0.40 mg/kg. If appropriate, Step 2 will not be conducted.)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• (1) Japanese (male, female) adult with symptomatic paroxysmal atrial fibrillation (AF)
• Written informed consent must be obtained on a voluntary basis before any assessment is performed.

(2) Age: 20 to less than 85 years of age (3) Weight: 40 kilograms(kg) or more BMI: 18.5 to less than 28.0 on screening examination(screening) (4) Past AF History: Event(s) as symptomatic AF with (at least) 2 hours or more AF lasting has (have) occurred at least once or more a half year (6 months) prior to the screening.

(5) Occurrence time of the latest AF: Record(s) of the patient portable electrocardiograph shows evidence to support that the latest AF has occurred within 3 hours to less than 3 days (72 hours) prior to an administration of the investigational product.

(6) The AF lasting prior to the administration: 12 lead electrocardiogram just prior to the administration shows that AF has not stopped.

(7) Excluded medication: Based on propositions of a principal investigator or a co-investigator(s), a patient can consent for discontinuation of below antiarrhythmic agents (the Vaughan-Williams classification) for at least 7 days after administration since an advanced registration. Nonetheless, if a period between the advanced registration and the administration is less than 7 days, it should be confirmed those agent has unadministered during 7 days prior to the administration.

[Vaughan-Williams classification] Antiarrhythmic drug group I Antiarrhythmic drug group III Antiarrhythmic drug group IV Bepridil (8) Excluded administration of amiodarone: It should be confirmed that amiodarone hydrochloride is not unadministered within one (1) year before the screening.

Exclusion Criteria

• (1) Heart failure (NYHA II, III, IV). Excluding palpitations induced by atrial fibrillation (AF) (2) Any atrioventricular block of first, second or third degree at the time of sinus rhythm (3) Any risk factor leads to Torsades de Pointes (TdP)

1. [0]: 440 ms or more in standard 12-lead electrocardiogram at the time of sinus rhythm within 3 months prior to administration

2. Hypokalemia or suspected to be hypokalemia:

One or more of serum potassium levels, obtained at any time during 6 months in advance of administration including pre-administration examination, has been 3.6 [1]/L or less.

3. Hypomagnesemia or suspected be hypomagnesemia: One or more of serum magnesium levels, obtained at any time during 6 months in advance of administration including pre-administration examination, has been 1.8 mg/dL or less.

4. T-wave abnormality of electrocardiogram at the time of sinus rhythm

5. Past medical history as fainting; syncope with unknown etiology or complicating illness.

6. Past own medical history or family medical history as long QT syndrome (4) Severe heart hypertrophy; Cardiomegaly: Septal Thickness of cardiac ultrasound has been exceeded over 15 mm.

(5) Left atrial dimension (parasternal long-axis view) of cardiac ultrasound has been exceeded over 45 mm.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aetas Pharma Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Kitasato University

OTHER

Sponsor Role: lead

Responsible Party

Yuji KUMAGAI

Yuji KUMAGAI, Professor, Kitasato University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Koga general Hospital

Koga, Ibaraki, Japan

Site Status: RECRUITING

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Site Status: RECRUITING

Sendai Cardiovascular Center

Sendai, Miyagi, Japan

Site Status: RECRUITING

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan

Site Status: RECRUITING

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Miwa Nonaka

Role: CONTACT

Phone: +81357916398

Email: m201-a@insti.kitasato-u.ac.jp

Facility Contacts

Koji Uchida

Role: primary

Kimiko Yamamura

Role: primary

Masahiro Yagi

Role: primary

Mariko Iyama

Role: primary

Masahiko Nakamura

Role: primary

Other Identifiers

M201-A-CT-002

Identifier Type: -

Identifier Source: org_study_id