Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Drug Drug Interaction · 1 trial · 1 indication
Maximum observed concentration (Cmax) for caffeine and its metabolite paraxanthine.
Time of occurrence of Cmax (Tmax) for caffeine and its metabolite paraxanthine.
Area under the plasma concentration vs. time curve from 0 to time of last measurable plasma concentration (AUC0-last) for caffeine and its metabolite paraxanthine.
Area under the plasma concentration vs. time curve from 0 to infinity (AUC0-inf) for caffeine and its metabolite paraxanthine.
Maximum observed concentration (Cmax) for Tolbutamide and its metabolites 4-hydroxy-tolbutamide and carboxy-tolbutamide.
Time of occurrence of Cmax (Tmax) for Tolbutamide and its metabolites 4-hydroxy-tolbutamide and carboxy-tolbutamide.
Area under the plasma concentration vs. time curve from 0 to time of last measurable plasma concentration (AUC0-last) for Tolbutamide and its metabolites 4-hydroxy-tolbutamide and carboxy-tolbutamide.
Area under the plasma concentration vs. time curve from 0 to infinity (AUC0-inf) for Tolbutamide and its metabolites 4-hydroxy-tolbutamide and carboxy-tolbutamide.
Maximum observed concentration (Cmax) for midazolam and its metabolite 1-hydroxy-midazolam.
Time of occurrence of Cmax (Tmax) for midazolam and its metabolite 1-hydroxy-midazolam.
Area under the plasma concentration vs. time curve from 0 to time of last measurable plasma concentration (AUC0-last) for midazolam and its metabolite 1-hydroxy-midazolam.
Area under the plasma concentration vs. time curve from 0 to to infinity (AUC0-inf) for midazolam and its metabolite 1-hydroxy-midazolam.
Maximum observed concentration (Cmax) for nintedanib and its metabolite BIBF 1202.
Time of occurrence of Cmax (Tmax) for nintedanib and its metabolite BIBF 1202.
Area under the plasma concentration vs. time curve from 0 to time of last measurable plasma concentration (AUC0-last) for nintedanib and its metabolite BIBF 1202.
Area under the plasma concentration vs. time curve from 0 to infinity (AUC0-inf) for nintedanib and its metabolite BIBF 1202.
| Arm | Type | Description |
|---|---|---|
| Experimental: C21 | EXPERIMENTAL | C21, single dose, oral administration twice daily, for 15 days |
| Name | Type | Description |
|---|---|---|
| Drug Drug Interaction | DRUG | The intervention phase consists of 3 periods: in period 1, the pharmacokinetics (PK) of all substrates will be evaluated in the absence of C21, in period 2, a potential inhibitory effect of C21 on the substrates be evaluated, and in period 3, the net effect of potential C21-mediated induction and inhibition on the substrates will be evaluated |
Inclusion Criteria: 1. Willing and able to give written informed consent for participation in the trial. 2. Healthy male, or healthy female subject of non-childbearing potential, aged 18 to 60 years, inclusive. 3. Body mass index ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit. 4. Medica...
Drug Drug Interaction refers to a clinical study evaluating how C21, a small molecule, affects the exposure of four other substrates in healthy volunteers. The study was conducted in Sweden and enrolled 19 participants aged 18 years and older. It is an investigational drug interaction trial, not a treatment for a specific disease.
Drug Drug Interaction is being developed by Vicore Pharma Holding AB, a biopharmaceutical company. The company's American Depositary Shares trade under the ticker symbol VCRE. The development program focuses on understanding how C21 interacts with other drugs in healthy volunteers.
Drug Drug Interaction is in Phase 1 clinical development. The single clinical trial, NCT05830799, has been completed. This phase typically involves initial studies in healthy volunteers to assess drug interactions and safety. The drug remains investigational and is not yet approved for any medical use.
Drug Drug Interaction has one completed clinical trial, NCT05830799, titled "A Trial to Evaluate the Impact of C21 on the Exposure of 4 Substrates in Healthy Volunteers." This Phase 1 study enrolled 19 healthy volunteers in Sweden and was not randomized, double-blind, or controlled. It assessed how C21 affects the exposure of four other drugs.
Drug Drug Interaction is not FDA approved. It is an investigational drug interaction study in Phase 1 clinical development. The completed trial, NCT05830799, evaluated the impact of C21 on the exposure of four substrates in healthy volunteers. Approval status for any therapeutic use has not been established.