Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Praziquantel
Cisticid · 1 trial · 1 indication
Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration.
The maximum observed plasma concentration of L-Praziquantel (L-PZQ).
| Arm | Type | Description |
|---|---|---|
| First Cisticid, Then Biltricide, Then Biltricide | EXPERIMENTAL | Cisticid (Test) in Treatment Period 1 followed by Biltricide (Reference) in Treatment Period 2 and Treatment Period 3. A washout period of 7 days will be maintained between 3 treatment periods. |
| First Biltricide, Then Cisticid, Then Biltricide | EXPERIMENTAL | Biltricide (Reference) in Treatment Period 1 followed by Cisticid (Test) in Treatment Period 2 and then Biltricide (Reference) in Treatment Period 3. A washout period of 7 days will be maintained between 3 treatment periods. |
| First Biltricide, Then Biltricide, Then Cisticid | EXPERIMENTAL | Biltricide (Reference) in Treatment Period 1 and Treatment Period 2 followed by Cisticid (Test) in Treatment Period 3. A washout period of 7 days will be maintained between 3 treatment periods. |
| Name | Type | Description |
|---|---|---|
| Cisticid | DRUG | Participants received single oral dose of 1200 mg (two 600 mg tablets) Cisticid (Test) on Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3). |
| Biltricide | DRUG | Participants received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2). |
Inclusion Criteria: * A male participant must agree to use and to have their female partners willing to use additional non-hormonal contraception (for example, condoms or occlusive cap with spermicide, non-hormonal intra-uterine device \[IUD\], previous sterilization of participant or his partner, ...
Cisticid is an investigational small molecule developed by Merck KGaA. It has been studied in a Phase 1 clinical trial conducted in Mexico. The specific disease or condition it is intended to treat has not been publicly disclosed, and the compound remains in early clinical development.
Cisticid is being developed by Merck KGaA, the German pharmaceutical and life sciences company whose shares trade over the counter in the United States under the ticker MKGAF. Merck KGaA is the sponsor of the clinical program evaluating the compound.
Cisticid is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. Because only early-stage testing has been conducted, Cisticid is investigational and has not been approved by the FDA for any indication.
Cisticid has been evaluated in one completed Phase 1 trial, NCT03437447, titled Praziquantel Bioequivalence Study. That trial enrolled 60 healthy male volunteers aged 18 years and older in Mexico. It was a randomized, controlled study, and no active trials of Cisticid are currently listed.
Cisticid is a small molecule, but its molecular target has not been publicly disclosed. Without a disclosed target or target class, its precise mechanism of action cannot be described. The compound has completed one Phase 1 trial in healthy volunteers, and further characterization of its pharmacology would come from ongoing development.