Evidence map›Paper›PMID 29877614›Full record

Trial reportClinical and translational science2018

Population Pharmacokinetic and Exposure-dizziness Modeling for a Metabotropic Glutamate Receptor Subtype 5 Negative Allosteric Modulator in Major Depressive Disorder Patients.

Valérie Cosson, Franziska Schaedeli-Stark, Mona Arab-Alameddine, Clarisse Chavanne, Elena Guerini, Michael Derks, Navita L Mallalieu

Abstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
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

7 authors.

Valérie CossonPharmaceutical Sciences Clinical Pharmacology, Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland.
Franziska Schaedeli-StarkPharmaceutical Sciences Clinical Pharmacology, Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland.
Mona Arab-AlameddinePharmaceutical Sciences Clinical Pharmacology, Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland.
Clarisse ChavannePharmaceutical Sciences Clinical Pharmacology, Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland.
Elena GueriniPharmaceutical Sciences Clinical Pharmacology, Roche Innovation Center Basel, F. Hoffmann-La Roche, Basel, Switzerland.
Michael DerksPharmaceutical Sciences Clinical Pharmacology, Roche Innovation Center Welwyn, Roche Products, Welwyn, UK.
Navita L MallalieuPharmaceutical Sciences Clinical Pharmacology, Roche Innovation Center New York, F. Hoffmann-La Roche, New York, New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dizziness, the most frequently observed adverse event in patients with major depressive disorder, was observed with basimglurant, a selective, orally active metabotropic glutamate receptor subtype 5 negative allosteric modulator. The potential relationship between dizziness and basimglurant exposure was explored. The pharmacokinetics of basimglurant was characterized with nonlinear mixed effects modeling using data from 288 trial participants enrolled in five clinical trials. The pharmacokinetics of basimglurant after daily oral administration of a modified release formulation was best described by a two-compartment disposition model with a transit compartment, lag time for the absorption, and first-order elimination. The largest covariate effects were the effect of smoking and male gender on apparent clearance followed by the effect of body weight on distribution volumes. Clearance was twofold higher in smokers and 40% higher in males. A logistic regression model showed a statistically significant correlation between basimglurant C

Indexed as

Models, BiologicalAllosteric RegulationDizzinessHumansImidazolesMajor Depressive DisorderPyridinesReceptor, Metabotropic Glutamate 52-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridineImidazolesPyridinesReceptor, Metabotropic Glutamate 5

Identifiers

PMID29877614
PMCPMC6132363

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.