Evidence map›Paper›PMID 33788154›Full record

Trial reportClinical drug investigation2021

First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT

Ramakrishna Nirogi, Gopinadh Bhyrapuneni, Nageswara Rao Muddana, Vinod Kumar Goyal, Santosh Kumar Pandey, Abdul Rasheed Mohammed, Jyothsna Ravula, Satish Jetta, Veera Raghava Chowdary Palacharla

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

9 authors.

Ramakrishna NirogiSuven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad, 500034, India. nvsrk@suven.com.ORCID http://orcid.org/0000-0002-2045-0784
Gopinadh BhyrapuneniSuven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad, 500034, India.
Nageswara Rao MuddanaSuven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad, 500034, India.
Vinod Kumar GoyalSuven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad, 500034, India.
Santosh Kumar PandeySuven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad, 500034, India.
Abdul Rasheed MohammedSuven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad, 500034, India.
Jyothsna RavulaSuven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad, 500034, India.
Satish JettaSuven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad, 500034, India.
Veera Raghava Chowdary PalacharlaSuven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad, 500034, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveSUVN-D4010 is a novel, potent, highly selective 5-HT

methodsSingle-ascending dose and multiple-ascending dose studies for 14 days were conducted in healthy adults using a randomized, double-blind design. The effects of food, sex, and age on SUVN-D4010 pharmacokinetics (25 mg single dose) were evaluated using an open-label, two-period, randomized, fed and fasted, crossover design. Pharmacokinetics and safety assessments were conducted throughout the study.

resultsSUVN-D4010 at a single dose up to 45 mg and multiple doses up to 40 mg once daily was found to be safe and well tolerated in healthy adults. The most frequently reported adverse events were headache and nausea. SUVN-D4010 exposure was dose proportional across the tested doses. Steady state was achieved on day 2 after once-daily dosing for 14 days. Food had no significant effect on the exposures but an increase in median time to attain the maximum plasma concentration (t

conclusionSUVN-D4010 was found to be safe and well tolerated in healthy human subjects. SUVN-D4010 followed linear pharmacokinetics across the dose range. Accumulation was in the range of 1.3- to 1.4-fold after multiple dosing. Renal excretion is not the major route of elimination. Food had no effect on the exposures but increased the t

Indexed as

AdultAgedArea Under CurveCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleSerotonin 5-HT4 Receptor AgonistsYoung AdultSerotonin 5-HT4 Receptor Agonists

Identifiers

What Socratic 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 Socratic graph.