Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed bioequivalence study. The drug is not approved and remains under investigation.
Cisticid is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 1 clinical development.
Cisticid is in Phase 1 clinical development. It has one completed Phase 1 trial, and no active trials are currently listed. The drug remains investigational and is not approved.
Cisticid has one completed Phase 1 trial, NCT03437447, a praziquantel bioequivalence study. The trial enrolled 60 healthy male participants in Mexico, aged 18 years and older. It was a controlled, randomized study.
Cisticid is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, with only a completed bioequivalence study in healthy volunteers.