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13 results on '"Wolford, Dennis"'

1. Orally Bioavailable Macrocyclic Peptide That Inhibits Binding of PCSK9 to the Low Density Lipoprotein Receptor

Author

Johns, Douglas G., Campeau, Louis-Charles, Banka, Puja, Bautmans, An, Bueters, Tjerk, Bianchi, Elisabetta, Branca, Danila, Bulger, Paul G., Crevecoeur, Inne, Ding, Fa-Xiang, Garbaccio, Robert M., Guetschow, Erik D., Guo, Yan, Ha, Sookhee N., Johnston, Jennifer M., Josien, Hubert, Kauh, Eunkyung A., Koeplinger, Kenneth A., Kuethe, Jeffrey T., Lai, Eseng, Lanning, Christine L., Lee, Anita Y.H., Li, Li, Nair, Anilkumar G., O’Neill, Edward A., Stoch, S. Aubrey, Thaisrivongs, David A., Tucker, Thomas J., Vachal, Petr, van Dyck, Kristien, Vanhoutte, Frederic P., Volckaert, Bram, Wolford, Dennis G., Xu, Andy, Zhao, Tian, Zhou, Dan, Zhou, Susan, Zhu, Xiaohong, Zokian, Hratch J., Walji, Abbas M., and Wood, Harold B.

Published
2023
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3. No Pharmacokinetic Interactions Between Elbasvir or Grazoprevir and Buprenorphine/Naloxone in Healthy Participants and Participants Receiving Stable Opioid Agonist Therapy

Author

Feng, Hwa‐Ping, Guo, Zifang, Caro, Luzelena, Marshall, William L., Liu, Fang, Panebianco, Deborah, Vaddady, Pavan, Barbour, April, Reitmann, Christina, Jumes, Patricia, Gilmartin, Jocelyn, Wolford, Dennis, Valesky, Robert, Martinho, Monika, Butterton, Joan R., Iwamoto, Marian, Fraser, Iain, Webster, Lynn, and Yeh, Wendy W.

Subjects
Adult, Cyclopropanes, Male, Antiviral Agents, Article, Young Adult, Quinoxalines, Opiate Substitution Treatment, Humans, Drug Interactions, Benzofurans, Sulfonamides, Research, Imidazoles, Articles, Middle Aged, Opioid-Related Disorders, Amides, Hepatitis C, Healthy Volunteers, Analgesics, Opioid, Area Under Curve, Drug Therapy, Combination, Female, Buprenorphine, Naloxone Drug Combination, Carbamates
Abstract

The aims of these phase I trials were to evaluate the pharmacokinetic interaction between elbasvir (EBR) or grazoprevir (GZR) and buprenorphine/naloxone (BUP/NAL). Trial 1 was a single‐dose trial in healthy participants. Trial 2 was a multiple‐dose trial in participants on BUP/NAL maintenance therapy. Coadministration of EBR or GZR with BUP/NAL had minimal effect on the pharmacokinetics of BUP/NAL, EBR, and GZR. The geometric mean ratios (GMRs (90% CI)) for BUP, norbuprenorphine, and NAL AUC0‐∞ were 0.98 (0.89–1.08), 0.97 (0.86–1.09), and 0.88 (0.78–1.00) in the presence/absence of EBR; 0.98 (0.81–1.19), 1.13 (0.97–1.32), and 1.10 (0.82–1.47) in the presence/absence of GZR. The GMRs (90% CI) for EBR and GZR AUC0‐∞ in the absence/presence of BUP/NAL were 1.22 (0.98–1.52) and 0.86 (0.63–1.18). In conclusion, no dose adjustment for BUP/NAL, EBR, or GZR is required for patients with HCV infection receiving EBR/GZR and BUP/NAL maintenance therapy.

Published
2018

4. A Phase 1 Randomized, Double‐Blind, Placebo‐Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK‐1654 in Healthy Adults

Author

Aliprantis, Antonios O., primary, Wolford, Dennis, additional, Caro, Luzelena, additional, Maas, Brian M., additional, Ma, Hua, additional, Montgomery, Diana L., additional, Sterling, Laura M., additional, Hunt, Allen, additional, Cox, Kara S., additional, Vora, Kalpit A., additional, Roadcap, Brad A., additional, Railkar, Radha A., additional, Lee, Andrew W., additional, Stoch, S. Aubrey, additional, and Lai, Eseng, additional

Published
2020
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6. A Phase 1 Randomized, Double‐Blind, Placebo‐Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK‐1654 in Healthy Adults.

Author

Aliprantis, Antonios O., Wolford, Dennis, Caro, Luzelena, Maas, Brian M., Ma, Hua, Montgomery, Diana L., Sterling, Laura M., Hunt, Allen, Cox, Kara S., Vora, Kalpit A., Roadcap, Brad A., Railkar, Radha A., Lee, Andrew W., Stoch, S. Aubrey, and Lai, Eseng

Subjects
*RESPIRATORY syncytial virus, *MONOCLONAL antibodies, *HUMAN metapneumovirus infection, *CHIMERIC proteins, *RESPIRATORY infections, *PHARMACOKINETICS, *BIOAVAILABILITY
Abstract

Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infection and related morbidity and mortality in infants. Passive immunization with an RSV‐neutralizing antibody can provide rapid protection to this vulnerable population. Proof‐of‐concept for this approach has been demonstrated by palivizumab; however, the use of this antibody is generally restricted to the highest‐risk infants due to monthly dosing requirements and its cost. To address the large unmet medical need for most infants, we are evaluating MK‐1654, a fully human RSV‐neutralizing antibody with half‐life extending mutations targeting site IV of the fusion protein. In this 2‐part, placebo‐controlled, double‐blind, first‐in‐human study, 152 healthy adults were randomized 3:1 to receive a single dose of MK‐1654 or placebo in 5 cohorts (100 or 300 mg as an intramuscular dose or 300, 1000, or 3000 mg as an intravenous dose). Safety, pharmacokinetics, antidrug antibodies, and RSV serum‐neutralizing antibody titers were evaluated through 1 year. MK‐1654 serum concentrations increased proportionally with dose and resulted in corresponding elevations in RSV serum‐neutralizing antibody titers. The antibody displayed a half‐life of 73 to 88 days and an estimated bioavailability of 69% at the 300‐mg dose. The overall safety profile of MK‐1654 was similar to placebo, and treatment‐emergent antidrug antibodies were low (2.6%) with no associated adverse events. These data support the continued development of MK‐1654 for the prevention of RSV disease in infants. [ABSTRACT FROM AUTHOR]

Published
2021
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7. Pharmacokinetic Interactions Between the Fixed‐Dose Combinations of Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine and Elbasvir/Grazoprevir in Healthy Adult Participants

Author

Feng, Hwa‐Ping, primary, Guo, Zifang, additional, Fandozzi, Christine, additional, Panebianco, Deborah, additional, Caro, Luzelena, additional, Wolford, Dennis, additional, Dreyer, Daniel P., additional, Valesky, Robert, additional, Martinho, Monika, additional, Rizk, Matthew L., additional, Iwamoto, Marian, additional, and Yeh, Wendy W., additional

Published
2019
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9. 1971. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of a Respiratory Syncytial Virus (RSV) Neutralizing Monoclonal Antibody (MK-1654) in Healthy Subjects

Author

Aliprantis, Antonios, primary, Wolford, Dennis, additional, Caro, Luzelena, additional, Maas, Brian, additional, Ma, Hua, additional, Vora, Kalpit, additional, Geng, Dong, additional, Railkar, Radha, additional, Lee, Andrew, additional, Sterling, Laura, additional, and Lai, Eseng, additional

Published
2018
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11. No Pharmacokinetic Interactions Between Elbasvir or Grazoprevir and Methadone in Participants Receiving Maintenance Opioid Agonist Therapy

Author

Feng, Hwa-Ping, primary, Guo, Zifang, additional, Caro, Luzelena, additional, Marshall, William L., additional, Liu, Fang, additional, Panebianco, Deborah, additional, Vaddady, Pavan, additional, Reitmann, Christina, additional, Jumes, Patricia, additional, Wolford, Dennis, additional, Fraser, Iain, additional, Valesky, Robert, additional, Martinho, Monika, additional, Butterton, Joan R., additional, Iwamoto, Marian, additional, Webster, Lynn, additional, and Yeh, Wendy W., additional

Published
2018
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