Evidence map›Paper›PMID 39535924›Full record

Trial reportClinical and translational science2024

A randomized, placebo-controlled first-in-human study of oral TQS-168 in healthy volunteers: Assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.

Jonas Hannestad, Steven Smith, Andrew Lam, Janet Hurt, Nicole Harada, Richard Kim, Abhirup Das, Juliana Brunello, Gareth Whitaker, David Chalmers and 7 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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. Trial
  2. 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

17 authors.

Jonas HannestadTranquis Therapeutics, Inc., Palo Alto, California, USA.ORCID 0000-0003-3772-4865
Steven SmithTranquis Therapeutics, Inc., Palo Alto, California, USA.ORCID 0009-0006-6593-1406
Andrew LamTranquis Therapeutics, Inc., Palo Alto, California, USA.
Janet HurtTranquis Therapeutics, Inc., Palo Alto, California, USA.
Nicole HaradaTranquis Therapeutics, Inc., Palo Alto, California, USA.
Richard KimTranquis Therapeutics, Inc., Palo Alto, California, USA.
Abhirup DasTranquis Therapeutics, Inc., Palo Alto, California, USA.
Juliana BrunelloTranquis Therapeutics, Inc., Palo Alto, California, USA.ORCID 0009-0008-3846-1458
Gareth WhitakerQuotient Sciences Ltd, Nottingham, UK.
David ChalmersQuotient Sciences Ltd, Nottingham, UK.
Faria SenjotiQuotient Sciences Ltd, Nottingham, UK.
Wu LinQuotient Sciences Ltd, Nottingham, UK.
James CoghillQuotient Sciences Ltd, Nottingham, UK.
Yogesh BansalQuotient Sciences Ltd, Nottingham, UK.
Sharan SidhuQuotient Sciences Ltd, Nottingham, UK.
Vanessa ZannQuotient Sciences Ltd, Nottingham, UK.ORCID 0000-0003-0747-181X
Enchi LiuTranquis Therapeutics, Inc., Palo Alto, California, USA.ORCID 0000-0002-7903-5569

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

TQS-168, a first-in-class small-molecule inducer of peroxisome proliferator-activated receptor gamma coactivator 1-alpha gene expression, is in development for the treatment of amyotrophic lateral sclerosis. A single-ascending-dose (SAD) and multiple-ascending-dose (MAD) study of TQS-168 was carried out in healthy male subjects to investigate safety, tolerability, pharmacokinetics (PK), food effect, and preliminary pharmacodynamic effects (PD). Since solubility enhancement could be beneficial, assessment of three formulations was incorporated into the study using an integrated rapid manufacturing and clinical testing approach. Dosing in the SAD part was initiated with a crystalline methylcellulose (MC) suspension, and then spray-dried dispersion (SDD) and hot-melt extrusion (HME) suspensions were evaluated. The HME and SDD formulations showed two and fourfold higher exposure than the MC suspension, respectively, and the SDD formulation was selected for progression to subsequent SAD and MAD cohorts, in which there was further investigation of the food effect on exposure in addition to assessments of safety, tolerability, PK, and PD. C

Indexed as

Food-Drug InteractionsHealthy VolunteersAdministration, OralAdultArea Under CurveCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodHumansMaleMethylcelluloseMiddle AgedPlacebosSpray DryingSuspensionsYoung AdultMethylcellulosePlacebosSuspensions

Identifiers

PMID39535924
PMCPMC11559592

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.