Evidence map›Paper›PMID 27489211›Full record

Trial reportClinical pharmacology in drug development2017

Assessment of the Pharmacokinetics, Pharmacodynamics, and Safety of Single Doses of TV-1106, a Long-Acting Growth Hormone, in Healthy Japanese and Caucasian Subjects.

Orit Cohen-Barak, Hadas Barkay, Michele Rasamoelisolo, Kathleen Butler, Kazumasa Yamada, Merav Bassan, Esther Yoon, Ofer Spiegelstein

Abstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2017. 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. Article
  2. Article
  3. Review
  4. Long-Acting Growth Hormone Preparations - Current Status and Future Considerations.The Journal of clinical endocrinology and metabolism · 2020
    Review
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.

Orit Cohen-BarakTeva Pharmaceuticals, Inc., Netanya, Israel.
Hadas BarkayTeva Pharmaceuticals, Inc., Netanya, Israel.
Michele RasamoelisoloTeva Pharmaceuticals, Inc., West Chester, PA, USA.
Kathleen ButlerTeva Pharmaceuticals Inc., Frazer, PA, USA.
Kazumasa YamadaTeva Pharmaceutical K.K., Tokyo, Japan.
Merav BassanTeva Pharmaceuticals, Inc., Netanya, Israel.
Esther YoonParexel Early Phase Clinical Unit, Los Angeles, CA, USA.
Ofer SpiegelsteinTeva Pharmaceuticals, Inc., Netanya, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

TV-1106 is a human serum albumin genetically fused to recombinant human growth hormone, designed to provide a long-acting alternative to daily growth hormone (GH) injections in patients with GH deficiency. This study investigated the pharmacokinetics, pharmacodynamics, and safety of single subcutaneous doses of TV-1106 (7.5, 15, 50, and 100 mg) in Japanese (n = 44) and caucasian (n = 44) healthy subjects. TV-1106 pharmacokinetics and pharmacodynamics were comparable in Japanese and caucasian populations. TV-1106 demonstrated relatively slow absorption (median t

Indexed as

AdultAsian PeopleDose-Response Relationship, DrugFemaleHealthy VolunteersHuman Growth HormoneHumansInjections, SubcutaneousInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IMaleRecombinant Fusion ProteinsSerum Albumin, HumanWhite PeopleYoung AdultHuman Growth HormoneIGF1 protein, humanIGFBP3 protein, humanInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IRecombinant Fusion ProteinsSerum Albumin, Humangrowth hormone deficiency (GHD)insulin-like growth factor (IGF-1)JapaneseTV-1106weekly hGH

Identifiers

PMID27489211
PMCPMC5516185

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.