Acute Leukemias Cancer
Conditions
Interventions
Part 1:
Day | Study compound | How much | How often
1 | Dextromethorphan | 30 mg | Once
2 to 4| - | - | -
5 | Emvododstat | 250 mg | Once
| Dextromethorphan | 30 mg | Once
Part 2:
Day | Study compou
Sponsors
PTC Therapeutics, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult, non-smokers (no use of tobacco products within 6 months prior to Screening), >=18 and 18.0 and =50.0 kg and
Exclusion criteria
Exclusion criteria: 1. For Part 1 (CYP2D6 substrate), subjects who are poor metabolizers of CYP2D6 isoenzymes are excluded. 2. Pregnant or lactating subjects or those sexually active subjects who are unwilling to comply with proper birth control methods; females of child-bearing potential must have a negative pregnancy test at Screening and during the Baseline Visit. 3. Aspartate aminotransferase or alanine aminotransferase above the upper limit of normal (ULN) at the time of Screening or Baseline. Values above ULN may be allowed if considered not clinically significant at the discretion of the Investigator. 4. International normalized ratio >=1.5×ULN at time of Screening or Baseline or clinically significant bleeding, as determined by the Investigator. 5. Serum creatinine >=1.5×ULN at time of Screening or Baseline. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoints for assessment of emvododstat as a perpetrator when administered with a CYP2D6 substrate (dextromethorphan) and BCRP substrate (rosuvastatin): PK Parameters: - Dextromethorphan and dextrophan: AUC0-t, AUC0-inf, Cmax - Rosuvastatin: AUC0-t, AUC0-inf, Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| PK Parameters: - Dextromethorphan and dextrophan: T1/2, Tmax, apparent clearance (CL/F), and terminal elimination rate constant (kel) - Rosuvastatin: T1/2, Tmax, kel, CL/F Endpoints for safety and tolerability assessment when emvododstat is administered in combination with a CYP2D6 (dextromethorphan) and BCRP (rosuvastatin) substrates: - Adverse events - Chemistry and hematology laboratory panels - 12 lead ECGs - Vital signs - Physical examinations | — |
Countries
Netherlands
Outcome results
None listed