Evidence map›Paper›PMID 29959802›Full record

Trial reportBritish journal of clinical pharmacology2018

Pharmacokinetics, metabolism and safety of deuterated L-DOPA (SD-1077)/carbidopa compared to L-DOPA/carbidopa following single oral dose administration in healthy subjects.

Frank Schneider, Lavi Erisson, Hooman Beygi, Margaret Bradbury, Orit Cohen-Barak, Igor D Grachev, Serge Guzy, Pippa S Loupe, Micha Levi, Mirna McDonald and 5 more

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
5.4field-weighted citation impact, top 5% of its field
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

9 citing papers in PubMed, 40 citations in OpenAlex.

  1. Trial
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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

15 authors at 6 institutions in 4 countries.

Frank SchneiderGlobal Research and Development, Teva Pharmaceutical Industries, Berlin, Germany.ORCID 0000-0001-5757-285X
Lavi ErissonGlobal Research and Development, Teva Pharmaceutical Industries, West Chester, PA, USA.
Hooman BeygiGlobal Research and Development, Teva Pharmaceutical Industries, West Chester, PA, USA.
Margaret BradburyFormerly Global Research and Development Teva Pharmaceuticals, currently Prana Biotechnology, San Francisco, CA, USA.
Orit Cohen-BarakGlobal Research and Development, Teva Pharmaceutical Industries, Netanya, Israel.
Igor D GrachevGlobal Research and Development, Teva Pharmaceutical Industries, Malvern, PA, USA.
Serge GuzyPop-Pharm Pharmacometrics Service, Albany, CA, USA.
Pippa S LoupeGlobal Research and Development, Teva Pharmaceutical Industries, Overland Park, KS, USA.
Micha LeviGlobal Research and Development, Teva Pharmaceutical Industries, West Chester, PA, USA.
Mirna McDonaldGlobal Research and Development, Teva Pharmaceutical Industries, West Chester, PA, USA.
Juha-Matti SavolaTeva Pharmaceuticals International GmbH, Basel, Switzerland.
Spyros PapapetropoulosMassachusetts General Hospital, Boston, MA, USA.
William G TracewellGlobal Research and Development, Teva Pharmaceutical Industries, West Chester, PA, USA.
Maria VelinovaPRA Health Sciences, Early Development Services, Groningen, the Netherlands.
Ofer SpiegelsteinGlobal Research and Development, Teva Pharmaceutical Industries, Netanya, Israel.
Teva Pharmaceuticals (United States) · USTeva Pharmaceuticals (Israel) · ILAlbany College of Pharmacy and Health Sciences · USMassachusetts General Hospital · USTeva Pharmaceuticals (Germany) · DETeva Pharmaceuticals (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSD-1077, a selectively deuterated precursor of dopamine (DA) structurally related to L-3,4-dihydroxyphenylalanine (L-DOPA), is under development for treatment of motor symptoms of Parkinson's disease. Preclinical models have shown slower metabolism of central deuterated DA. The present study investigated the peripheral pharmacokinetics (PK), metabolism and safety of SD-1077.

methodsPlasma and urine PK of drug and metabolites and safety after a single oral 150 mg SD-1077 dose were compared to 150 mg L-DOPA, each in combination with 37.5 mg carbidopa (CD) in a double-blind, two-period, crossover study in healthy volunteers (n = 16).

resultsGeometric least squares mean ratios (GMRs) and 90% confidence intervals (90% CI) of SD-1077 vs. L-DOPA for C

conclusionsSD-1077/CD demonstrated the potential to prolong exposure to central DA at comparable peripheral PK and safety to the reference L-DOPA/CD combination. A single dose of SD-1077 is safe for further clinical development in Parkinson's disease patients.

Indexed as

Administration, OralAdultAntiparkinson AgentsArea Under CurveCarbidopaCross-Over StudiesDeuteriumDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHealthy VolunteersHumansLevodopaMaleParkinson DiseaseAntiparkinson AgentsCarbidopaDeuteriumLevodopaProdrugsdeuterateddeuteriumL-DOPAmetabolismParkinson's diseasepharmacokineticsSD-1077

Identifiers

PMID29959802
PMCPMC6138493
OpenAlexW2810435294

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.