Danielle Armas
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View article: Assessment of <scp>QT</scp> Interval Prolongation Using Concentration– <scp>QT</scp> Modeling for Iptacopan, an Oral Complement Factor B Inhibitor, in Healthy Individuals
Assessment of <span>QT</span> Interval Prolongation Using Concentration– <span>QT</span> Modeling for Iptacopan, an Oral Complement Factor B Inhibitor, in Healthy Individuals Open
To assess cardiac and safety parameters of iptacopan (an oral, selective, reversible, small‐molecule factor B inhibitor), we conducted a phase I, single ascending dose (SAD), exposure–response study (A2107) instead of a traditional thoroug…
View article: A phase I thorough <scp>QT</scp>/<scp>QTc</scp> study evaluating therapeutic and supratherapeutic doses of avacopan in healthy participants
A phase I thorough <span>QT</span>/<span>QTc</span> study evaluating therapeutic and supratherapeutic doses of avacopan in healthy participants Open
This phase I thorough QTc, double‐blind, randomized, placebo‐ and positive‐controlled, parallel group, multiple‐dose study evaluated avacopan's effect on cardiac repolarization using concentration‐QTc (C‐QTc) as the primary analysis. Avaco…
View article: Pharmacokinetic Evaluation of the CYP3A4 and CYP2C9 Drug‐Drug Interaction of Avacopan in 2 Open‐Label Studies in Healthy Participants
Pharmacokinetic Evaluation of the CYP3A4 and CYP2C9 Drug‐Drug Interaction of Avacopan in 2 Open‐Label Studies in Healthy Participants Open
Avacopan, a complement 5a receptor (C5aR) antagonist approved for treating severe active antineutrophil cytoplasmic autoantibody (ANCA)‐associated vasculitis, was evaluated in 2 clinical drug‐drug interaction studies. The studies assessed …
View article: A Phase 1 Dose-Escalation Study of the Cardiac Myosin Inhibitor Aficamten in Healthy Participants
A Phase 1 Dose-Escalation Study of the Cardiac Myosin Inhibitor Aficamten in Healthy Participants Open
This phase 1, randomized, double-blind, placebo-controlled study of aficamten (formerly CK-3773274) in healthy adults identified a pharmacologically active range of doses and exposures. At doses that were pharmacologically active (single d…
View article: Repeat subcutaneous administration of casirivimab and imdevimab in adults is well-tolerated and prevents the occurrence of COVID-19
Repeat subcutaneous administration of casirivimab and imdevimab in adults is well-tolerated and prevents the occurrence of COVID-19 Open
Repeat monthly administration of 1200 mg SC CAS+IMD was well-tolerated, demonstrated low immunogenicity, and showed a substantial risk reduction in COVID-19 occurrence.
View article: Repeat Subcutaneous Administration of REGEN-COV<sup>®</sup> in Adults is Well-Tolerated and Prevents the Occurrence of COVID-19
Repeat Subcutaneous Administration of REGEN-COV<sup>®</sup> in Adults is Well-Tolerated and Prevents the Occurrence of COVID-19 Open
Background Data show that a single dose of casirivimab and imdevimab (REGEN-COV ® ) is effective in treating hospitalized individuals and outpatients with COVID-19 and in post-exposure prophylaxis. We present results from a phase 1, double…
View article: Lack of a Clinically Meaningful Drug Interaction Between the HIV‐1 Antiretroviral Agents Islatravir, Dolutegravir, and Tenofovir Disoproxil Fumarate
Lack of a Clinically Meaningful Drug Interaction Between the HIV‐1 Antiretroviral Agents Islatravir, Dolutegravir, and Tenofovir Disoproxil Fumarate Open
Islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, is in clinical development for the treatment and prevention of HIV‐1 infection. Because islatravir may be coadministered with other antiretroviral age…
View article: Bioequivalence and food effect of a fixed‐dose combination of macitentan and tadalafil: Adaptive design in the COVID‐19 pandemic
Bioequivalence and food effect of a fixed‐dose combination of macitentan and tadalafil: Adaptive design in the COVID‐19 pandemic Open
The COVID‐19 pandemic has forced clinical studies to accommodate imposed limitations. In this study, the bioequivalence part could not be conducted as planned. Thus, the aim was to demonstrate bioequivalence, using an adaptive study design…
View article: A Four-Way, Cross-Over Design, Randomized, Double-Blinded, Placebo-&Active-Controlled Study for the Evaluation of the Effect of a Supratherapeutic Dose of Sofpironium Bromide Gel, 15% Applied Topically on the QT/QTc Intervals in Adult Healthy Volunteers
A Four-Way, Cross-Over Design, Randomized, Double-Blinded, Placebo-&Active-Controlled Study for the Evaluation of the Effect of a Supratherapeutic Dose of Sofpironium Bromide Gel, 15% Applied Topically on the QT/QTc Intervals in Adult Healthy Volunteers Open
not available.
View article: Pharmacokinetic Drug–Drug Interaction of Apalutamide, Part 1: Clinical Studies in Healthy Men and Patients with Castration-Resistant Prostate Cancer
Pharmacokinetic Drug–Drug Interaction of Apalutamide, Part 1: Clinical Studies in Healthy Men and Patients with Castration-Resistant Prostate Cancer Open
Co-administration of apalutamide with CYP3A4, CYP2C19, CYP2C9, P-gp, BCRP or OATP1B1 substrates may cause loss of activity for these medications. Therefore, appropriate mitigation strategies are recommended.
View article: Atogepant Has No Clinically Relevant Effects on the Pharmacokinetics of an Ethinyl Estradiol/Levonorgestrel Oral Contraceptive in Healthy Female Participants
Atogepant Has No Clinically Relevant Effects on the Pharmacokinetics of an Ethinyl Estradiol/Levonorgestrel Oral Contraceptive in Healthy Female Participants Open
The incidence of migraine is higher among women than men and peaks during the reproductive years, when contraceptive medication use is common. Atogepant, a potent, selective antagonist of the calcitonin gene‒related peptide receptor—in dev…
View article: First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults
First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults Open
VL-2397 is an antifungal drug with a novel mechanism of action, rapid fungicidal in vitro activity, and potent in vivo activity against Aspergillus fumigatus , including azole-resistant strains. VL2397-101, a phase 1 first-in-human, random…
View article: A Phase 1 Pharmacokinetic Study of Cysteamine Bitartrate Delayed-Release Capsules Following Oral Administration with Orange Juice, Water, or Omeprazole in Cystinosis
A Phase 1 Pharmacokinetic Study of Cysteamine Bitartrate Delayed-Release Capsules Following Oral Administration with Orange Juice, Water, or Omeprazole in Cystinosis Open
Horizon Pharma, Inc.
View article: Pharmacokinetics and pharmacodynamics of single and multiple doses of the glucagon receptor antagonist LGD‐6972 in healthy subjects and subjects with type 2 diabetes mellitus
Pharmacokinetics and pharmacodynamics of single and multiple doses of the glucagon receptor antagonist LGD‐6972 in healthy subjects and subjects with type 2 diabetes mellitus Open
Aim To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of a novel, oral glucagon receptor antagonist, LGD‐6972, in healthy subjects and subjects with type 2 diabetes (T2DM). Methods In …