Covid 19 Research Clinical Trials by Shray Alag

Mobocertinib

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Correlated Drug Terms (0)

	Name (Synonyms)	Correlation

Correlated MeSH Terms (2)

	Name (Synonyms)	Correlation
D051437	Renal Insufficiency, NIH	0.29
D008107	Liver Diseases NIH	0.24

Correlated HPO Terms (2)

	Name (Synonyms)	Correlation
HP:0000083	Renal insufficiency HPO	0.29
HP:0001392	Abnormality of the liver HPO	0.24

Clinical Trials

Navigate: Correlations HPO

There are 2 clinical trials

1 A Phase 1 Pharmacokinetic Study of Oral Mobocertinib in Subjects With Severe Renal Impairment and Normal Renal Function

The purpose of this study is to characterize the single-dose plasma and urine PK of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with severe RI compared to matched-healthy participants with normal renal function.

NCT04056455

Conditions

Renal Impairment
Healthy Volunteers

Interventions

Drug: Mobocertinib

MeSH:Renal Insufficiency

HPO:Renal insufficiency

Primary Outcomes

Measure: Cmax: Maximum Observed Plasma Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: AUCinf,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: AUClast: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: AUClast,u: Area Under the Unbound Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Combined Molar Unbound Cmax, for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Combined Molar Unbound AUClast, for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Combined Molar Unbound AUCinf, for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: : Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: λz: Terminal Disposition Phase Rate Constant for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: CL/F: Apparent Clearance After Extravascular Administration for Mobocertinib

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for Mobocertinib

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Aet: Amount of Drug Excreted in Urine From Time 0 to time t for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose

Measure: fe,t: Fraction of Administered Dose Excreted in Urine From Time 0 to Time t for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose

Measure: CLR: Renal Clearance for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose

Secondary Outcomes

Measure: Plasma Protein Binding of Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 at multiple time points (up to 24 hours) post-dose

Measure: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)

Time: Baseline up to 30 days after the last of study drug (Day 31)

2 Phase 1 Pharmacokinetics and Safety Study of Oral Mobocertinib in Subjects With Moderate or Severe Hepatic Impairment and Normal Hepatic Function

The purpose of this study is to characterize the single-dose plasma PK of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with moderate and/or severe HI compared to matched-healthy participants with normal hepatic function.

NCT04056468

Conditions

Hepatic Impairment
Healthy Volunteers

Interventions

Drug: Mobocertinib

MeSH:Liver Diseases

HPO:Abnormality of the liver Decreased liver function Elevated hepatic transaminase

Primary Outcomes

Measure: Cmax: Maximum Observed Plasma Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and its Active Metabolites (AP32960 and AP32914)

Time: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Measure: λz: Terminal Elimination Rate Constant for Mobocertinib and its Active Metabolites (AP32960 and AP32914)