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This is a Phase 1 non randomized, open label, single dose, parallel cohort study to investigate the effect of hepatic impairment on the PK, safety and tolerability of PF 04965842.
Full description
A minimum of 24 subjects with normal, mild or moderate hepatic function will be enrolled into the study, with approximately 8 subjects in each cohort. The Child Pugh classification score will be utilized to assess entry criteria and to assign subjects into the appropriate hepatic impairment group. For individual subjects, the total maximum duration of study participation from the Screening visit to the end of clinical research unit (CRU) stay is approximately 31 days and approximately 63 days from the Screening visit to the Follow up contact.
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Inclusion criteria
Additional Inclusion Criteria for subjects with hepatic impairment:
Exclusion criteria
Additional exclusion criteria for subjects with hepatic impairment:
24 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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