Phase 3
Completed N=21
Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants
Source: ClinicalTrials.gov NCT01392469 ↗Enrolled (actual)
21
Serious AEs
6.3%
Results posted
Jun 2021
Primary outcomePrimary: Geometric Mean Ratio of Dose Normalized Area Under the Curve From Time Zero to Tau (AUCtau) for Bosentan Before and After Imatinib Administrations — 93.3; 109; 131 hr*ng/mL/mg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Ratio of Dose Normalized Area Under the Curve From Time Zero to Tau (AUCtau) for Bosentan Before and After Imatinib Administrations |
93.3; 109; 131 | — |
| PRIMARY Geometric Mean Ratio of Dose Normalized AUCtau for Sildenafil Before and After Imatinib Administrations |
7.22; 9.82; 12.3 | — |
| PRIMARY Geometric Mean Ratio of Dose Normalized Maximum Plasma Concentration (Cmax) for Bosentan Before and After Imatinib Administrations |
21.9; 21.8; 23.4 | — |
| PRIMARY Geometric Mean Ratio of Dose Normalized Cmax for Sildenafil Before and After Imatinib Administrations |
2.44; 3.14; 3.81 | — |
| SECONDARY Number of Participants With At Least One or More Adverse Events (AEs) |
10; 9; 16 | — |
| SECONDARY Dose Normalized Cmax of Imatinib and CGP74588 (Active Metabolite of Imatinib) |
7.55; 6.71; 1.37; 1.39 | — |
| SECONDARY Dose Normalized AUCtau of Imatinib and CGP74588 (Active Metabolite of Imatinib) |
90.9; 88.4; 19.3; 20.6 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with Pulmonary arterial hypertension (PAH) in World Health Organization (WHO) Diagnostic Group 1, with pulmonary vascular resistance > 800 dyne*sec*cm^-5,
- On stable doses of bosentan and sildenafil
Exclusion Criteria
- Other diagnosis of PAH in World Health Organization (WHO) Diagnostic Group 1 such as congenital large or small unrepaired systemic to pulmonary shunts, portal hypertension, Human Immunodeficiency Virus (HIV) infection, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic teleangiectasia, hemoglobinopathies, myeloproliferative disorders, veno-occlusive pulmonary disease
- Significant lung diseases not related to PAH
- Significant cardiovascular system disorders, hematological system disorders, liver insufficiency
- Significant diseases in other organ system.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01392469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.