NCT03676322

Brief Summary

The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics (PD), and explore the food effect of M5049 in healthy male and female participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2019

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

10 months

First QC Date

September 17, 2018

Last Update Submit

December 2, 2019

Conditions

Healthy

Keywords

PharmacokineticsM5049

Outcome Measures

Primary Outcomes (12)

  • Part A: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

    Day 1 up to Day 21

  • Part A: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings

    Number of participants with clinically significant changes will be reported.

    Day 1 up to Day 21

  • Part B: Occurrence and Severity of TEAEs and SAEs

    Day 1 up to Day 33

  • Part B: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings

    Number of participants with clinically significant changes will be reported.

    Day 1 up to Day 33

  • Part C: Maximum Observed Plasma Concentration (Cmax) of M5049

    Pre-dose up to Day 6

  • Part C: Time to Reach Maximum Plasma Concentration (tmax) of M5049

    Pre-dose up to Day 6

  • Part C: Elimination Rate Constant (λz) of M5049

    Pre-dose up to Day 6

  • Part C: Apparent Terminal Half-life (t1/2) of M5049

    Pre-dose up to Day 6

  • Part C: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049

    Pre-dose up to Day 6

  • Part C: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf)

    Pre-dose up to Day 6

  • Part C: Total Body Clearance (CL/f) of M5049

    Pre-dose up to Day 6

  • Part C: Apparent Volume of Distribution (Vz/f) of M5049

    Pre-dose up to Day 6

Secondary Outcomes (31)

  • Part A: Maximum Observed Blood Concentration (Cmax) of M5049

    Pre-dose up to Day 6

  • Part A: Time to Reach Maximum Plasma Concentration (tmax) of M5049

    Pre-dose up to Day 6

  • Part A: Elimination Rate Constant (λz) of M5049

    Pre-dose up to Day 6

  • Part A: Apparent Terminal Half-life (t1/2) of M5049

    Pre-dose up to Day 6

  • Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049

    Pre-dose up to Day 6

  • +26 more secondary outcomes

Study Arms (5)

Part A: M5049

EXPERIMENTAL
Drug: M5049

Part A: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Part B: M5049

EXPERIMENTAL
Drug: M5049

Part B: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Part C: M5049

EXPERIMENTAL
Drug: M5049

Interventions

M5049DRUG

Participants will receive single ascending oral dose of M5049 in Part A. Participants will receive multiple ascending oral dose of M5049 once daily for 14 days or twice daily for 13 days followed by a single dose on Day 14 in the morning in Part B. Participants will receive a single oral dose of M5049 under fed conditions in Part C.

Part A: M5049Part B: M5049Part C: M5049
PlaceboDRUG

Participants will receive placebo matched to M5049.

Part A: PlaceboPart B: Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body weight between 50 to 100 kilogram (kg)
  • Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m\^2)

You may not qualify if:

  • 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
  • History of splenectomy
  • History of epilepsy, other neurological disorders, or neuropsychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, 89231, Germany

Location

Study Officials

  • Medical Responsible

    Merck KGaA, Darmstadt, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 18, 2018

Study Start

September 20, 2018

Primary Completion

July 26, 2019

Study Completion

July 26, 2019

Last Updated

December 3, 2019

Record last verified: 2019-11

Locations

DE(1)