Labcorp Drug Development Clinical Research Unit
Dallas, Texas, 75247, United States
NCT Number: NCT05255276
A Phase 1 Open-label, Two-cohort, One-sequence Crossover Study to Investigate the Effect of P glycoprotein Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics, Safety, and Tolerability of Sitravatinib in Healthy Subjects.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Dallas, Texas, 75247, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
50 mg Sitravatinib on Day 1 (Group 1A)
Other names: MGCD516
100 mg Sitravatinib on Day 1 (Group 2A)
Other names: MGCD516
Itraconazole QD from Day 9 to Day 18, and Sitravatinib 50 mg at Day 12 (Group 1B)
Other names: Protonix
Rifampin QD from Day 9 to Day 22, and Sitravatinib 100 mg at Day 16 (Group 2B)
Other names: Pepcid
Time frame: Up to Day 168 hours after dosing
Maximum observed plasma concentration
Time frame: Up to 168 hours after dosing
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Up to 168 hours after dosing
Area under the curve from time zero to the last measured time point
Time frame: Up to 168 hours after dosing
Terminal elimination half-life
Time frame: Up to 168 hours after dosing
Apparent total plasma clearance when dosed orally
Time frame: Up to 168 hours after dosing
Apparent volume of distribution when dosed orally
Time frame: Up to 168 hours after dosing
Unbound fraction
Time frame: Up to 12 weeks from screening
Incidence and severity of AEs
Mirati Therapeutics Inc.
Industry
A Phase 1 Open-label, Two-cohort, One-sequence Crossover Study to Investigator the Effect of P-glycoprotien Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics, Safety, and Tolerability of Sitravatinib in Health Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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