A Phase 1 interventional study of tucatinib and placebo in Healthy, sponsored by Seagen Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by Seagen Inc. · Phase 1, Interventional, and Treatment
This study is looking at how the study drug, tucatinib, affects the heart. Tucatinib is being studied as a possible treatment for breast cancer. This study will recruit healthy volunteers. There are 3 parts in the study. Each volunteer will be in all 3 parts. One part will be to take the study drug, the second part will be to take a placebo (pill with no medicine), and the third part will be to take moxifloxacin. The volunteers will only know what part of the study they are in when they take moxifloxacin. For the study drug and placebo parts, volunteers will take 2 pills by mouth for 5 days. For the moxifloxacin part, volunteers will take 1 pill by mouth for 1 day.
This study will evaluate the effects of a steady state therapeutic dose of tucatinib on QTcF (QT interval corrected for heart rate using Fridericia's method) in healthy individuals. In this design, study treatment will be dosed in 3 sequential treatment periods:
Treatment A: Oral doses of 300mg tucatinib for 5 days
Treatment B: Oral doses of matching placebo for tucatinib for 5 days
Treatment C: A single oral dose of 400 mg of moxifloxacin
Patients will be randomized based on 2-Williams-square design to 1 of 6 treatment sequences to maintain the study blind for tucatinib and placebo.
Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
tucatinib + placebo + moxifloxacin (administered in sequential treatment periods)
Drug: tucatinib · Drug: placebo · Drug: moxifloxacin
moxifloxacin + tucatinib + placebo (administered in sequential treatment periods)
Drug: tucatinib · Drug: placebo · Drug: moxifloxacin
placebo + moxifloxacin + tucatinib (administered in sequential treatment periods)
Drug: tucatinib · Drug: placebo · Drug: moxifloxacin
moxifloxacin + placebo + tucatinib (administered in sequential treatment periods)
Drug: tucatinib · Drug: placebo · Drug: moxifloxacin
tucatinib + moxifloxacin + placebo (administered in sequential treatment periods)
Drug: tucatinib · Drug: placebo · Drug: moxifloxacin
placebo + tucatinib + moxifloxacin (administered in sequential treatment periods)
Drug: tucatinib · Drug: placebo · Drug: moxifloxacin
300mg oral dose
Matching placebo for tucatinib
400mg single oral dose
Placebo-corrected change-from-baseline in QTcF
QTcF is the QT interval corrected for heart rate using Fridericia's method.
Time frame: Up to 32 days
Change from baseline in heart rate (HR)
Time frame: Up to 32 days
Change from baseline in QTcF
Time frame: Up to 32 days
Change from baseline in PR interval
Time frame: Up to 32 days
Change from baseline in QRS interval
Time frame: Up to 32 days
Placebo-corrected change from baseline in HR
Time frame: Up to 32 days
Placebo-corrected change from baseline in PR interval
Time frame: Up to 32 days
Placebo-corrected change from baseline in QRS interval
Time frame: Up to 32 days
• Number of participants who experience increases in absolute QTcF interval values >450 msec
Time frame: Up to 32 days
• Number of participants who experience QTcF interval changes from predose baseline of >30msec
Time frame: Up to 32 days
• Number of participants who experience an increase in PR interval from predose baseline of >25% to a PR >200 msec
Time frame: Up to 32 days
• Number of participants who experience an increase in QRS interval from predose baseline >25% to a QRS >120 msec
Time frame: Up to 32 days
• Number of participants who experience a decrease in heart rate >25% from baseline to a heart rate <50
Time frame: Up to 32 days
• Number of participants who experience an increase in heart rate >25% from baseline to a heart rate >100
Time frame: Up to 32 days
Frequency of treatment-emergent changes of T-wave morphology and U-wave presence
Time frame: Up to 32 days
Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUC[0-inf]) for tucatinib and ONT-993
Time frame: Up to 26 days
AUC from time 0 to the time of the last quantifiable concentration for tucatinib and ONT-993
Time frame: Up to 26 days
Percentage of AUC[0-inf] due to extrapolation for tucatinib and ONT-993
Time frame: Up to 26 days
Maximum observed concentration for tucatinib and ONT-993
Time frame: Up to 26 days
Time of maximum observed concentration for tucatinib and ONT-993
Time frame: Up to 26 days
Apparent terminal elimination half-life for tucatinib and ONT-993
Time frame: Up to 26 days
Apparent total clearance for tucatinib
Time frame: Up to 26 days
Apparent volume of distribution during the terminal phase for tucatinib
Time frame: Up to 26 days
Metabolic ratio based on AUC for ONT-993
Time frame: Up to 26 days
Incidence of adverse events (AEs)
Time frame: Up to 32 days
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Seagen Inc.