Research Papers

This database includes peer-reviewed publications authored by TB Alliance staff. Use the tags on the left to filter by subject, or search for a particular author or term using the search bar.

Tag: Clinical Trial Results

Displaying 29 papers

Randomized dose-ranging study of the 14-day early bactericidal activity of bedaquiline (TMC207) in patients withsputum microscopy smear-positive pulmonary tuberculosis

Publication: Diacon AH, Dawson R, Von Groote-Bidlingmaier F, et. al. Randomized Dose-Ranging Study of the 14-Day Early Bactericidal Activity of Bedaquiline (TMC207) in Patients with Sputum Microscopy Smear-Positive Pulmonary Tuberculosis. Antimicrob Agents Chemother.

5/2013

Tags: Bedaquiline (TMC-207), Clinical Development, Clinical Trial Results, Pharmacokinetics

Evaluation of pharmacokinetic interaction between PA-824 and midazolam in healthy adult subjects

Publication: Winter H, Egizi E, Erondu N, et. al. Evaluation of Pharmacokinetic Interaction between PA-824 and Midazolam in Healthy Adult Subjects. Antimicrob Agents Chemother. 2013 Aug; 57(8): 3699–3703.doi: 10.1128/AAC.02632-12

4/2013

Tags: Clinical Development, Clinical Trial Results, Pretomanid/PA-824

Phase II dose-ranging trial of the early bactericidal activity of PA-824

Publication: Diacon AH, Dawson R, du Bois J, et. al. Phase II dose-ranging trial of the early bactericidal activity of PA-824. Antimicrob Agents Chemother. 2012 Jun;56(6):3027-31. doi: 10.1128/AAC.06125-11

3/2012

Tags: Clinical Development, Clinical Trial Results, Pharmacokinetics, Pretomanid/PA-824

14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial.

Publication: Diacon AH, Dawson R, von Groote-Bidlingmaier F, et. al. 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. Lancet. 2012 Sep 15;380(9846):986-93. doi: 10.1016/S0140-6736(12)61080-0.

9/2011

Tags: Bedaquiline (TMC-207), Clinical Development, Clinical Trial Results, MDR-TB, Moxifloxacin, NC-001, PaMZ, Pretomanid/PA-824, Pyrazinamide

Development of a population pharmacokinetic model for taranabant, a cannibinoid-1 receptor inverse agonist

Publication: Li X (Susie), Nielsen J, Cirincione B, et. al. Development of a Population Pharmacokinetic Model for Taranabant, a Cannibinoid-1 Receptor Inverse Agonist. The AAPS Journal. 2010;12(4):537-547. doi:10.1208/s12248-010-9212-2.

6/2010

Tags: Clinical Trial Results, Drug Discovery, Drug Targets, Pharmacokinetics, Preclinical Models

Early Bactericidal Activity and Pharmacokinetics of PA-824 in Smear-Positive Tuberculosis Patients (AAC01354-09)

Publication: Diacon AH, Dawson R, Hanekom M, et. al. Early bactericidal activity and pharmacokinetics of PA-824 in smear-positive tuberculosis patients. Antimicrob Agents Chemother. 2010 Aug;54(8):3402-7. doi: 10.1128/AAC.01354-09.

5/2010

Tags: Clinical Development, Clinical Trial Results, Moxifloxacin, NC-001, PaMZ, Pretomanid/PA-824, Pyrazinamide

Safety, Tolerability, and Pharmacokinetics of PA-824 in Healthy Subjects

Publication: Ginsberg AM, Laurenzi MW, Rouse DJ, Whitney KD, Spigelman, MK. Safety, tolerability, and pharmacokinetics of PA-824 in healthy subjects. Antimicrob Agents Chemother. 2009 Sep;53(9):3720-5. doi: 10.1128/AAC.00106-09.

6/2009

Tags: Clinical Development, Clinical Trial Results, Pharmacodynamics, Pretomanid/PA-824

Assessment of the Effects of the Nitroimidazo-Oxazine PA-824 on

Publication: Ginsberg AM, Laurenzi MW, Rouse DJ, Whitney KD, Spigelman MK. Assessment of the effects of the nitroimidazo-oxazine PA-824 on renal function in healthy subjects. Antimicrob Agents Chemother. 2009 Sep;53(9):3726-33. doi: 10.1128/AAC.00112-09

6/2009

Tags: Advocacy, Clinical Development, Clinical Trial Results, Pretomanid/PA-824

The ethics of non-inferiority trials

Publication: Nunn AJ, Meredith SK, Spigelman MK, Ginsberg AM, Gillespie SH. The ethics of non-inferiority trials. Lancet. 2008 Mar 15;371(9616):895; author reply 896-7. doi: 10.1016/S0140-6736(08)60404-3.

3/2008

Tags: Advocacy, Clinical Development, Clinical Trial Results, Editorials, Policy, Trial Design

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