Evidence map›Paper›PMID 24628035›Full record

Trial reportBritish journal of clinical pharmacology2014

Tolerability, pharmacokinetics and pharmacodynamics of TA-8995, a selective cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects.

John Ford, Matt Lawson, David Fowler, Nobuko Maruyama, Seiji Mito, Koichi Tomiyasu, Shuji Kinoshita, Chisa Suzuki, Atsuhiro Kawaguchi, Patrick Round and 5 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
4.4field-weighted citation impact, top 6% 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

26 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
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  4. A Multidose Study to Examine the Effect of Food on Evacetrapib Exposure at Steady State.Journal of cardiovascular pharmacology and therapeutics · 2015
    Trial
  5. Obicetrapib safety analysis: Pooled phase 3 clinical trial experience.American journal of preventive cardiology · 2026
    Article
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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 7 institutions in 4 countries.

John FordDezima Pharma BV, Naarden, The Netherlands; Xention Ltd, Cambridge, UK.
Matt Lawson
David Fowler
Nobuko Maruyama
Seiji Mito
Koichi Tomiyasu
Shuji Kinoshita
Chisa Suzuki
Atsuhiro Kawaguchi
Patrick Round
Malcolm Boyce
Steve Warrington
Werner Weber
Sander van Deventer
John J P Kastelein
Mitsubishi Corporation (United Kingdom) · GBMitsubishi Tanabe Pharma CorporationAM–Pharma (Netherlands) · NLHammersmith Medicines Research · GBMitsubishi Group (Japan) · JPXention (United Kingdom) · GBHamburg Institut (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTwo double-blind, randomized studies were conducted to assess the tolerability, pharmacokinetics and pharmacodynamics of oral TA-8995, a new cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects.

methodsStudy 1: Subjects received single doses of TA-8995 or placebo (fasted). Doses were 5, 10, 25, 50 (fed/fasted), 100 and 150 mg (Caucasian males, 18-55 years), 25 mg (Caucasian males, > 65 years and Caucasian females, 18-55 years), 25, 50, 100 and 150 mg (Japanese males, 18-55 years). Study 2: Caucasian males (18-55 years) received 1, 2.5, 10 or 25 mg once daily TA-8995 or placebo for 21-28 days. Blood and urine for pharmacokinetics and/or pharmacodynamics were collected. Tolerability was assessed by adverse events, vital signs, electrocardiograms and laboratory safety tests.

resultsPeak TA-8995 concentrations occurred approximately 4 h post-dose. Mean half-lives ranged from 81 to 166 h, without an obvious dose relationship. Exposure increased less than proportionally to dose. TA-8995 was not excreted in urine. Following 2.5 to 25 mg once daily dosing, TA-8995 demonstrated nearly complete inhibition of CETP activity (92-99%), increased high density lipoprotein-cholesterol (HDL-C) by 96 to 140% and decreased low density liporotein-cholesterol (LDL-C) by 40% to 53%. There were dose-related increases in apolipoproteins A-1 and E, HDL2-C and HDL3-C, and decreases in apolipoprotein B and lipoprotein A. There was no evidence of significant effects of age, gender, ethnicity or food on pharmacokinetics or pharmacodynamics. All doses were well tolerated.

conclusionsTA-8995 is a potent CETP inhibitor and warrants further investigation.

Indexed as

Asian PeopleWhite PeopleAdolescentAdultCholesterol Ester Transfer ProteinsCholesterol, HDLCholesterol, LDLDose-Response Relationship, DrugDouble-Blind MethodElectrocardiographyFemaleHalf-LifeHumansMaleMiddle AgedQuinolinesCholesterol Ester Transfer ProteinsCholesterol, HDLCholesterol, LDLQuinolinesTA-8995apolipoproteinscardiovascular diseasescholesterolcoronary diseasehypercholesterolaemia

Identifiers

PMID24628035
PMCPMC4243901
OpenAlexW2100595390

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.