Study of M5049 in Healthy Japanese and Caucasian Participants

Healthy Clinical Trial

Official title:

A Phase I, Open-label, Single-dose, Sequential Dose Group Study of Orally Administered M5049 Tablet Formulation in Healthy Japanese and Caucasian Participants to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880213
• Other study ID #: MS200569_0005
• Secondary ID: 2020-005408-20
• Status: Completed
• Phase: Phase 1
• Start date: May 6, 2021
• Est. completion date: November 23, 2021

Study information

• Verified date: March 2022
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and determine the safety, tolerability and pharmacokinetics of single-doses of M5049 up to 3 dose levels administered as film-coated tablet under fasted conditions in healthy Japanese and Caucasian participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Japanese participants must be first generation (born in Japan) with both biological parents and all 4 biological grandparents being Japanese native born. Caucasian participants must have both biological parents and 4 biological grandparents of Caucasian descent

• Overtly healthy participants as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring (blood pressure, heart rate and 12-Lead resting ECG)

• Participants with body weight within 45 to 90 kilograms (kg) (female) and 55 to 90 kg (male) and body mass index (BMI) between 18.5 and 29.9 kilograms per meter square (kg/m^2)

• A Caucasian participant will be matched by body weight (± 20% body weight [kg]), height (± 15% height [centimeter (cm) ]) and sex to each Japanese participant

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Participants with history of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant

• Participants with history of relevant drug hypersensitivity

• Participants with history of splenectomy, epilepsy, other neurological disorders or neuropsychiatric conditions

• Participants with history of a tuberculosis and positive Screening test for hepatitis B surface antigen

• Participants with history of alcoholism or drug abuse

• Other protocol defined exclusion criteria could apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• M5049
Participants will receive single oral dose of film-coated tablet M5049 at low dose on Day 1 under fasted condition.
• M5049
Participants will receive single oral dose of film-coated tablet M5049 at medium dose on Day 1 under fasted condition.
• M5049
Participants will receive single oral dose of film-coated tablet M5049 at high dose on Day 1 under fasted condition.

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd.	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (tlast) (AUC0-tlast) of M5049		Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Area Under Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of M5049		Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Maximum Observed Plasma Concentration (Cmax) of M5049		Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Primary	Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death		Baseline up to Day 8
Primary	Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters		Baseline up to Day 3
Primary	Number of Participants with Clinically Significant Changes from Baseline in Vital Signs		Baseline up to Day 3
Primary	Number of Participants with Clinically Significant Changes from Baseline in 12-lead Electrocardiogram (ECGs) Findings		Baseline up to Day 3
Secondary	Area Under the Plasma Concentration-Time Curve From Time Zero to 48 Hours Post-dose (AUC0-48) of M5049		Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Secondary	Time to Reach Maximum Plasma Concentration (tmax) of M5049		Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Secondary	Terminal Half-life (t1/2) of M5049		Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Secondary	Apparent Total Body Clearance (CL/f) of M5049		Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Secondary	Apparent Volume of Distribution (Vz/f) During Terminal Phase of M5049		Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose

External Links

•   Trial Awareness and Transparency website