Healthy
Conditions
Keywords
Phase 1 clinical study, Tirfostin, L-Carnitine, Biological Safety, Pharmacokinetics
Brief 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.
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.
Interventions
COMBINATION_PRODUCTTirfostina/L-Carnitina
Estudio clínico fase 1 para describir la seguridad biológica y la farmacocinética de la tirfostina AG-17
Sponsors
Molecule X LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator) The random assignment codes to the administration sequence will be under the protection of the Statistics Department. The Analytical Unit, the group of researchers from the Clinical Unit (medical staff) and the IS will remain blinded during the conduct of the study, the processing and analysis of the biological samples and in this way avoid biasing the results generated. Once the Clinical Phase is over, the opening code for the issuance of the Clinical Report and the Safety Report will be shared with the group of researchers of the Clinical Unit (medical staff).
Intervention model description
Assess 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance assessment | 30 days | * 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 |
Countries
Mexico
Outcome results
None listed