Evidence map›Paper›PMID 30377854›Full record

Trial reportThe AAPS journal2018

Population Pharmacokinetics of AL-335 and Its Two Main Metabolites (ALS-022399, ALS-022227) in Monotherapy and in Combination with Odalasvir and/or Simeprevir.

Elodie Valade, Thomas N Kakuda, Matthew W McClure, Christopher Westland, Belén Valenzuela, Sivi Ouwerkerk-Mahadevan, Juan José Perez-Ruixo, Oliver Ackaert

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in The AAPS journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Elodie ValadeJanssen Research and Development, Global Clinical Pharmacology, Turnhoutseweg 30, B-2340, Beerse, Belgium.
Thomas N KakudaAlios BioPharma, Inc., part of the Janssen Pharmaceutical Companies, South San Francisco, California, USA.
Matthew W McClureAlios BioPharma, Inc., part of the Janssen Pharmaceutical Companies, South San Francisco, California, USA.
Christopher WestlandAlios BioPharma, Inc., part of the Janssen Pharmaceutical Companies, South San Francisco, California, USA.
Belén ValenzuelaSGS Exprimo NV, Mechelen, Belgium.
Sivi Ouwerkerk-MahadevanJanssen Research and Development, Global Clinical Pharmacology, Turnhoutseweg 30, B-2340, Beerse, Belgium.
Juan José Perez-RuixoJanssen Research and Development, Global Clinical Pharmacology, Turnhoutseweg 30, B-2340, Beerse, Belgium.
Oliver AckaertJanssen Research and Development, Global Clinical Pharmacology, Turnhoutseweg 30, B-2340, Beerse, Belgium. oackaert@ITS.JNJ.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of the current study was to characterize the time course of plasma concentrations of AL-335 and its main metabolites (ALS-022399 and ALS-022227) after oral administration in healthy and hepatitis C virus (HCV)-infected subjects, in monotherapy as well as in combination with simeprevir and/or odalasvir. AL-335, ALS-022399, and ALS-022227 plasma concentrations from subjects receiving 800 mg of AL-335 orally once daily (qd) as monotherapy or in combination were pooled and analyzed using a nonlinear mixed effect modeling approach. The typical values (between subject variability) of AL-335 and ALS-022399 apparent linear clearances were 3300 L/h (33.9%) and 1910 L/h (30.0%), respectively. ALS-022227 elimination was characterized as a nonlinear process, with typical values of V

Indexed as

Biological Variation, PopulationAdministration, OralAlanineAntiviral AgentsBenzimidazolesCarbamatesDrug Administration ScheduleDrug InteractionsDrug Therapy, CombinationHealthy VolunteersHepatitis C, ChronicHumansIndolesPhosphoramidesSimeprevirUridineadafosbuvirAlanineAntiviral AgentsBenzimidazolesCarbamatesIndolesodalasvirPhosphoramidesSimeprevirUridinedirect-acting antiviral (DAA) drugshepatitis C virus (HCV)nonlinear mixed effects modelingpharmacokineticsuridine nucleoside analog

Identifiers

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.