Evidence map›Paper›PMID 30324422›Full record

Trial reportPharmaceutical research2018

Application of a Novel 'Make and Test in Parallel' Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects.

Sravanthi Cheeti, Hao Helen Hou, Eric Nelson, Helen Walker, Buyun Chen, Roland Morley, Mary Gates, Luna Musib, Sandhya Girish, Srikumar Sahasranaman and 1 more

Erratum issuedAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pharmaceutical research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Sravanthi CheetiGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA. cheeti.sravanthi@gene.com.ORCID http://orcid.org/0000-0003-2933-6328
Hao Helen HouGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA.
Eric NelsonGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA.
Helen WalkerQuotient Sciences, Mere Way, Ruddington, Nottingham, UK.
Buyun ChenGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA.
Roland MorleyGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA.
Mary GatesGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA.
Luna MusibGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA.
Sandhya GirishGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA.
Srikumar SahasranamanGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA.
Lichuan LiuGenentech, Inc., 1 DNA Way, MS# 463A, Genentech, South San Francisco, California, 94080, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeGDC-0810, administered orally, was used in Phase I and II clinical studies to treat estrogen receptor positive breast cancers. It contains N-methyl-D-glucamine (NMG) salt of GDC-0810 with 10% sodium lauryl sulfate (SLS) as a surfactant and 15% sodium bicarbonate (NaHCO

methodsRapidFACT®, a streamlined, data-driven drug product optimization platform was used to bridge Phase I/II and Phase III formulations of GDC-0810. Five prototype formulations, varying in either the form of active pharmaceutical ingredient and/or the levels of the excipients SLS and NaHCO

resultsThe study successfully identified a Phase III formulation with a reduced SLS content, which when administered following a low-fat meal, gave comparable pharmacokinetic exposure to the Phase I/II formulation administered under the same conditions.

conclusionsOur novel 'Make and Test in Parallel' approach enabled optimization of GDC-0810 formulation in a time- and cost-efficient fashion.

Indexed as

Drug CompoundingAdministration, OralAgedAntineoplastic AgentsBiological AvailabilityBreast NeoplasmsCinnamatesCross-Over StudiesExcipientsFemaleFood-Drug InteractionsHumansIndazolesMeglumineMiddle AgedReceptors, Estrogen3-(4-(2-(2-chloro-4-fluorophenyl)-1-(1H-indazol-5-yl)but-1-en-1-yl)phenyl)acrylic acidAntineoplastic AgentsCinnamatesExcipientsIndazolesMeglumineReceptors, EstrogenSodium Dodecyl SulfateSurface-Active Agentsfood effectformulation optimizationGDC-0810pharmacokineticsrelative bioavailability

Identifiers

PMID30324422
PMCPMC6208608

What OpenQuestion holds

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Registered trials

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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.