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

NCT05487781 | Unknown Early Phase 1 DMC

• 1 other identifier: F1-TIR-036/0821
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Phase 1 clinical study; Tirfostin; L-Carnitine; Biological Safety; Pharmacokinetics

Outcome Measures

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

  30 days

Study Arms (3)

Group 1

EXPERIMENTAL

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

Combination Product: Tirfostina/L-Carnitina

Group 2

EXPERIMENTAL

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

Combination Product: Tirfostina/L-Carnitina

Group 3

EXPERIMENTAL

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

Combination Product: Tirfostina/L-Carnitina

Interventions

Tirfostina/L-Carnitina COMBINATION_PRODUCT

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

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Signature of the informed consent for participation in this study, by the IS.
• 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.

Sponsors & Collaborators

• Molecule X LLC: lead

Study Sites (1)

Pharmet, S.A de C.V.

Mexico City, Azcapotzalco, 02230, Mexico

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: August 4, 2022
• Study Start: May 24, 2022
• Primary Completion: June 28, 2022
• Study Completion: July 29, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)