HealthyEarly Phase 1NCT05487781
Phase 1 Clinical Study to Describe Biological Safety and Pharmacokinetics of Tyrphostin
A Early Phase 1 study testing Tirfostina/L-Carnitina in people with Healthy, run by Molecule X LLC at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tirfostina/L-Carnitina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- 24 May 2022to 29 Jul 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Clinical Study To Describe the Biological Safety and Pharmacokinetics of Tyrphostin AG-17 Present in Oral Solid Formulations 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
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.
- Conditions
- Healthy
- Being tested
- Tirfostina/L-Carnitina
- Keywords
- Phase 1 clinical study, Tirfostin, L-Carnitine, Biological Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tirfostina/L-CarnitinaCombination product
Estudio clínico fase 1 para describir la seguridad biológica y la farmacocinética de la tirfostina AG-17
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Tyrphostin AG-17 content 10 mg with 700 mg of L-Carnitine tartrate Receives: Combination Product: Tirfostina/L-Carnitina |
| Group 2 | Experimental | Tyrphostin AG-17 content 3.3 mg with 700 mg of L-Carnitine tartrate Receives: Combination Product: Tirfostina/L-Carnitina |
| Group 3 | Experimental | Tyrphostin AG-17 content 1 mg with 700 mg of L-Carnitine tartrate Receives: Combination Product: Tirfostina/L-Carnitina |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start24 May 2022
- Primary completion28 Jun 2022
- Study completion29 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molecule X LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487781
- Sponsor's protocol ID
- F1-TIR-036/0821
- Status last verified
- Aug 2022
- First submitted
- 1 Mar 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Study To Describe the Biological Safety and Pharmacokinetics of Tyrphostin AG-17 Present in Oral Solid Formulations 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
- ClinicalTrials.gov ID
- NCT05487781
- Acronym / sponsor ID
- F1-TIR-036/0821
- Conditions
- Healthy
- Keywords
- Phase 1 clinical study, Tirfostin, L-Carnitine, Biological Safety, Pharmacokinetics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Molecule X LLCIndustry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 29 Jul 2022 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Combination Product: Tirfostina/L-CarnitinaTyrphostin AG-17 content 10 mg with 700 mg of L-Carnitine tartrate |
| Group 2 | Experimental | Combination Product: Tirfostina/L-CarnitinaTyrphostin AG-17 content 3.3 mg with 700 mg of L-Carnitine tartrate |
| Group 3 | Experimental | Combination Product: Tirfostina/L-CarnitinaTyrphostin AG-17 content 1 mg with 700 mg of L-Carnitine tartrate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tirfostina/L-CarnitinaEstudio clínico fase 1 para describir la seguridad biológica y la farmacocinética de la tirfostina AG-17 | Combination product | Group 1, Group 2, Group 3 |
Primary outcome
Tolerance assessment
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tirfostina/L-Carnitina in people with Healthy, run by Molecule X LLC at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance assessment (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.