Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial

Frantz, Robert P; McLaughlin, Vallerie V; Sahay, Sandeep; Escribano Subías, Pilar; Zolty, Ronald L; Benza, Raymond L; Channick, Richard N; Chin, Kelly M; Hemnes, Anna R; Howard, Luke S; Sitbon, Olivier; Vachiéry, Jean-Luc; Zamanian, Roham T; Cravets, Matt; Roscigno, Robert F; Mottola, David; Osterhout, Robin; Bruey, Jean-Marie; Elman, Erin; Tompkins, Cindy-ann; Parsley, Ed; Aranda, Richard; Zisman, Lawrence S; Ghofrani, Hossein-Ardeschir; Adir, Yochai; Baillie, Timothy; Baratz, David; Burger, Charles; Chakinala, Murali M.; Cifrián Martínez, Jose Manual; Delcroix, Marion; Dwyer, Nathan; Elwing, Jean M.; Fisher, Micah; Franco, Veronica; Grünig, Ekkehard; Highland, Kristin; Hill, Nicholas; Hirani, Naushad; Hoeper, Marius; Jansa, Pavel; Keogh, Anne; Kingrey, John; Lopez-Meseguer, Manuel; McConnell, John W.; Mehta, Sanjay; Melendres-Groves, Lana; Opitz, Christian; Pepke-Zaba, Joanna; Pillutla, Priya; Rahaghi, Franck; Raina, Amresh; Raviv, Yael; Robinson, Jeffrey; Ryan, John; Sager, Jeffrey; Shapiro, Shelley; Simon, Marc; Smith, Kerri; Sobol, Irina R.; Sood, Namita; Spikes, Leslie A.; Stadler, Stefan; Stevens, Wendy; Sulica, Roxana; White, R. James

doi:10.1016/s2213-2600(24)00072-9

The Lancet Respiratory Medicine

2024

DOI: 10.1016/s2213-2600(24)00072-9

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Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial

Robert P Frantz,

Vallerie V McLaughlin,

Sandeep Sahay

et al.

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Cited by 11 publications

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Phase 1 Studies to Assess Inhaled Seralutinib as a Perpetrator or a Victim of Drug‐Drug Interactions in Healthy Participants

Li,

Parsley,

Cravets

et al. 2024

Clinical Pharm in Drug Dev

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Seralutinib, an inhaled, small‐molecule tyrosine kinase inhibitor in clinical development for the treatment of pulmonary arterial hypertension (PAH), was evaluated for its potential as a perpetrator or victim of a metabolic and transporter‐based drug‐drug interactions in 2 phase 1 studies. In study 1, 24 participants received a cocktail of probe substrates: caffeine (CYP1A2), montelukast (CYP2C8), flurbiprofen (CYP2C9), midazolam (CYP3A), and pravastatin (OATP1B1/1B3), plus digoxin (P‐gp) with or without seralutinib. In study 2, 19 participants received seralutinib with/without itraconazole, a strong CYP3A inhibitor, or fosaprepitant, a weak CYP3A inhibitor. Geometric least‐squares mean ratios and 90% confidence intervals for maximum observed concentration (Cmax) and area under the plasma concentration‐time curve (AUC) were obtained. Safety was monitored throughout the studies. All adverse events were mild or moderate in severity. Seralutinib coadministration increased AUC for midazolam 3.03‐fold and caffeine 1.32‐fold. The coadministration increased digoxin Cmax 1.28‐fold. Seralutinib did not meaningfully alter Cmax and AUC for montelukast, flurbiprofen, or pravastatin. Fosaprepitant and itraconazole increased seralutinib AUC 1.08‐ and 1.84‐fold, respectively. Seralutinib is a moderate CYP3A inhibitor and a weak CYP1A2 inhibitor; it slightly inhibits P‐gp. Seralutinib exposure is minimally affected by a weak CYP3A inhibitor but is substantially increased by a strong CYP3A inhibitor.

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Phase 1 Studies to Assess Inhaled Seralutinib as a Perpetrator or a Victim of Drug‐Drug Interactions in Healthy Participants

Li,

Parsley,

Cravets

et al. 2024

Clinical Pharm in Drug Dev

View full text Add to dashboard Cite

show abstract

Tailoring oral anticoagulant treatment in the era of multi-drug therapies for PAH and CTEPH

Escal,

Poenou,

Delavenne

et al. 2024

Blood Reviews

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Advances in the potential of nebulized inhalation for the treatment of pulmonary arterial hypertension

Lu,

Baima,

et al. 2024

Current Problems in Cardiology

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Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial

Cited by 11 publications

References 50 publications

Phase 1 Studies to Assess Inhaled Seralutinib as a Perpetrator or a Victim of Drug‐Drug Interactions in Healthy Participants

Phase 1 Studies to Assess Inhaled Seralutinib as a Perpetrator or a Victim of Drug‐Drug Interactions in Healthy Participants

Tailoring oral anticoagulant treatment in the era of multi-drug therapies for PAH and CTEPH

Advances in the potential of nebulized inhalation for the treatment of pulmonary arterial hypertension

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