Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-3543-020 | Other Identifier | MSD |
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
Researchers have designed a study medicine called bomedemstat (MK-3543) as a new way to treat certain rare blood diseases.
The purpose of this study is to learn what happens to bomedemstat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to bomedemstat in the body when it is given alone and after multiple doses of another medicine called carbamazepine (CBZ).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bomedemstat + Carbamazepine | Experimental | A single dose of bomedemstat will be administered On Day 1 of Period 1. There will be a washout of 7 days between bomedemstat dosing in Period 1 and the first carbamazepine (CBZ) dose in Period 2. In Period 2, CBZ will be administered twice daily (BID) for 17 consecutive days, with a single dose of bomedemstat coadministered with the morning dose on Day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bomedemstat | Drug | Oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat | AUC0-inf for bomedemstat in plasma will be determined | Predose and at designated timepoints up to 168 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 66 days |
| Number of participants who discontinue study treatment due to an AE |
Not provided
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
History or presence of any of the following:
History of cancer
Regular user of cannabis products within 6 months before entering the study.
Unable to stop using or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days before entering the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. ( Site 0001) | Tempe | Arizona | 85283 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000730033 | bomedemstat |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| carbamazepine | Drug | Oral extended-release capsule |
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Up to approximately 25 days |
| Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of bomedemstat | AUC0-last for bomedemstat in plasma will be determined | Predose and at designated timepoints up to 168 hours postdose |
| Area under the concentration versus time curve from 0 to 24 hours after dosing (AUC0-24) of bomedemstat | AUC0-24 for bomedemstat in plasma will be determined | Predose and at designated timepoints up to 24 hours postdose |
| Maximum observed concentration (Cmax) of bomedemstat | Cmax for bomedemstat in plasma will be determined | Predose and at designated timepoints up to 168 hours postdose |
| Maximum observed concentration 24 hours after dosing (C24) bomedemstat | Cmax for bomedemstat in plasma will be determined | Predose and at designated timepoints up to 24 hours postdose |
| Time to maximum concentration (Tmax) of bomedemstat | Tmax for bomedemstat in plasma will be determined | Predose and at designated timepoints up to 168 hours postdose |
| Apparent terminal half-life (t1/2) of bomedemstat | t1/2 for bomedemstat in plasma will be determined | Predose and at designated timepoints up to 168 hours postdose |
| Apparent clearance (CL/F) of bomedemstat | CL/F for bomedemstat in plasma will be determined | Predose and at designated timepoints up to 168 hours postdose |
| Apparent volume of distribution during terminal phase (Vz/F) of bomedemstat in plasma | Vz/F for bomedemstat in plasma will be determined | Predose and at designated timepoints up to 168 hours postdose |