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Status unknownNCT05487781Updated Aug 4, 2022

Phase 1 Clinical Study to Describe Biological Safety and Pharmacokinetics of Tyrphostin

An Early Phase 1 interventional study of Tirfostina/L-Carnitina in Healthy, sponsored by Molecule X LLC. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Molecule X LLC · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Evaluate the biological safety and pharmacokinetics of tyrphostin AG-17 present in the solid oral formulations of the fixed-dose combination, in three different concentrations of the compound tyrphostin AG-17 contained 10 mg, 3.3 mg and 1 mg, respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in healthy research subjects of Mexican nationality.

Read the detailed description

Describe the tolerance of the fixed-dose combination, in three different concentrations of the compound tyrphostin AG-17, containing 10 mg, 3.3 mg and 1 mg, respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in research subjects. healthy Mexican nationals, describing: type, frequency, duration, consequence, relationship with clinical history, management, follow-up; criteria: seriousness, severity; and classification of the AE or ADRs in accordance with the current NOM-220-SSA1 and estimate if there are differences by gender.

Assess the effects on body functions of the fixed dose combination, in three different concentrations of the compound tyrphostin AG-17 content 10 mg, 3.3 mg and 1 mg respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in healthy research subjects of Mexican nationality through the measurement of physiological markers and estimate if there are differences by gender.

Obtain the biological blood samples necessary for the quantification of the compound tyrphostin AG-17 in concentrations of 10 mg, 3.3 mg and 1 mg in accordance with Good Clinical Practices, always taking care to protect the vulnerability and integrity of the research subjects.

Quantifying the compound tyrphostin AG-17 with a previously validated bioanalytical method.

Estimate the pharmacokinetic parameters of the compound tyrphostin AG-17 at concentrations of 10 mg, 3.3 mg and 1 mg.

Describe the pharmacokinetic parameters of the compound tyrphostin AG-17 in concentrations of 10 mg, 3.3 mg and 1 mg in terms of Cmax, AUC0-t, AUC0-inf and as secondary parameters AUCExt, TMR, Tmax, Ke, t½, Vd and CL and estimate if there are differences by gender.

Establish the possible linearity of the compound tyrphostin AG-17 in concentrations of 10 mg, 3.3 mg and 1 mg.

Correlate the pharmacokinetic markers with the presence of AE or ADRs, with the hemodynamic markers and with the physiological markers and present a dynamic profile of the compound under investigation to propose a pharmacological response that is of potential further interest.

02

Conditions studied

  • Healthy

Keywords

  • Phase 1 clinical study
  • Tirfostin
  • L-Carnitine
  • Biological Safety
  • Pharmacokinetics
03

In context

Lead sponsor

This is the only study on the registry with Molecule X LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Research subjects aged: between 18 and 55 years.
  • Sex: 24 men and 24 women.
  • Weight: Research subjects with Body Mass Index between 18-27 kg/m2.
  • Research subjects with a diagnosis of "HEALTHY"; For this, a clinical history, medical examination, physical examination will be carried out in addition to taking samples to perform clinical analyzes (complete blood count with differential count, to evaluate hematological function, blood chemistry that evaluates pancreatic, renal, hepatic function, cardiac risk, metabolic function, biosafety tests, studies to rule out the presence of hepatitis B and C, HIV and VDRL, general urine test, fasting,). The results of the laboratory tests will be reviewed according to the reference values given by the laboratory and/or the reference values of Instruction I-DCL-VAL-030 "Range of normal values of laboratory tests", the tests The biosafety tests will have to have a NON-REACTIVE result and the cabinet studies (ECG) will have to have a NORMAL diagnosis granted by the Pharmometrica medical staff that evaluates them.
  • Research subjects with NEGATIVE results on qualitative drug of abuse tests, breathalyzer and rapid urine pregnancy test (for females), at the beginning of the study.
  • Based on the foregoing, the medical staff will determine whether the research subject has the physical capacity to participate in the study. Healthy will be understood as the research subject that meets all the inclusion criteria and does not meet any exclusion criteria.
  • Signature of the informed consent for participation in this study, by the IS.

Exclusion criteria

Exclusion Criteria:

  • Research subjects with a medical history of allergies.
  • Research subjects who have ingested alcoholic beverages, tobacco or xanthines within 48 hours prior to the study.
  • Research subjects who have consumed grapefruit, grape, strawberry juice (generally red fruits such as blackberries or blueberries), spicy or charcoal-cooked foods 72 h prior to the study.
  • Research subjects who have participated in clinical research studies of any molecule, within 3 months prior to the study date.
  • Research subjects who were hospitalized for any reason or were seriously ill within 60 days prior to the study.
  • Research subjects who have donated or lost 450 mL or more of blood within 45 days prior to the study.
  • Research subjects with disease that require the use of medications Research subjects with medical history of cardiovascular, gastrointestinal, hepatic and/or renal insufficiency.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Group 1

    Tyrphostin AG-17 content 10 mg with 700 mg of L-Carnitine tartrate

    Combination Product: Tirfostina/L-Carnitina

  • Experimental
    Group 2

    Tyrphostin AG-17 content 3.3 mg with 700 mg of L-Carnitine tartrate

    Combination Product: Tirfostina/L-Carnitina

  • Experimental
    Group 3

    Tyrphostin AG-17 content 1 mg with 700 mg of L-Carnitine tartrate

    Combination Product: Tirfostina/L-Carnitina

Interventions

  • Combination productTirfostina/L-Carnitina

    Estudio clínico fase 1 para describir la seguridad biológica y la farmacocinética de la tirfostina AG-17

06

What researchers measure

Primary outcomes

  1. Tolerance assessment

    * Description: type, frequency, duration, consequence, relationship with clinical history, management, follow-up * Criteria: severity (serious \[serious\] and non-serious), severity (mild, moderate and severe) * Classification: certain, likely, possible, unlikely, conditional/unclassified, not evaluable/unclassifiable

    Time frame: 30 days

07

Study locations

1 site
  • Pharmet, S.A de C.V.
    Ciudad de México, Azcapotzalco 02230, Mexico
08

References and documents

Individual participant data

Plan to share: No — The blood samples obtained as a result of this study will be used to describe a possible change and/or damage in the organism and for the quantification of tyrphostin AG-17, as well as all the data obtained by this research will be evaluated maintaining its confidentiality, adjusting its compliance with the Federal Law on Protection of Personal Data Held by Private Parties

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05487781
Lead sponsor
Molecule X LLC
Responsible party
Sponsor
First posted
Aug 4, 2022
Start date
May 24, 2022
Primary completion
Jun 28, 2022
Completion
Jul 29, 2022 (estimated)
Last update
Aug 4, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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