Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.
The study drug, MRT-6160, is experimental. This is the first study in which MRT-6160 will be given to humans.
Part 1: Subjects will receive a single oral dose of MRT-6160 or placebo on Day 1
Part 2: Subjects will receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days
Detailed Description:
The purpose of this study is to:
Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-6160 in healthy adult subjects
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose | Experimental | Single Ascending Dose of either: MRT-6160 or matching placebo |
|
| Multiple Ascending Dose | Experimental | Multiple Ascending Dose of either: MRT-6160 or matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRT-6160 | Drug | Orally administered tablets or capsules of MRT-6160 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of single ascending doses of MRT-6160 in healthy adult subjects | Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0 | 6 weeks |
| To evaluate the safety and tolerability of multiple ascending doses of MRT-6160 in healthy adult subjects | Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0 | 7.5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of single dose or multiple doses of MRT-6160 on the heart rate (HR)-corrected QT (QTc) interval by assessing the concentration QT (C-QT) relationship using exposure-response modelling in healthy adult subjects. | 6 - 8 weeks | |
| To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| CRO | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Tempe | Arizona | 85283 | United States | ||
| Celerion |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sequential Ascending Doses, Multiple Ascending Doses
Not provided
Not provided
Not provided
| Placebo | Drug | Orally administered tablets or capsules of placebo |
|
Peak plasma Concentration (Cmax) |
| 6 - 8 weeks |
| To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal | Area under the plasma concentration versus time (AUC) | 6 - 8 weeks |
| Lincoln |
| Nebraska |
| 68502 |
| United States |