SNPMiner Trials (Home Page)
Report for Mutation A827G
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase 1a, Randomized, Double-blinded, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ELX-02 in Healthy Adult Volunteers
Phase 1 Single Ascending Dose Study in Normal Healthy Volunteers
NCT03292302 Genetic Disease Nonsense Mutation Drug: Placebo Drug: ELX-02 MeSH:Genetic Diseases, Inborn
4. Presence of mitochondrial mutations making subject susceptible to aminoglycoside toxicity (A1555G, C1494T, T1095C, A827G, 1-BP DEL, 961T, C INS). 5. Subjects with any history of ear disease or surgeries, persistent dizziness or persistent tinnitus. --- A1555G --- --- C1494T --- --- T1095C --- --- A827G ---
Primary Outcomes
Description: Incidence and characteristics of adverse events occurring following single doses of ELX-02
Measure: Adverse Events Time: 0-10 daysDescription: Cmax will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.
Measure: Pharmacokinetics: Maximum plasma concentration (Cmax) Time: 0-10 daysDescription: tmax will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.
Measure: Pharmacokinetics: Time at which Cmax occurs (tmax) Time: 0-10 daysDescription: AUC24h will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.
Measure: Pharmacokinetics: Area under the plasma concentration-time curve calculated from time of administration to time 24h (AUC24h) Time: 0-10 daysDescription: AUC48h will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.
Measure: Pharmacokinetics: Area under the plasma concentration-time curve calculated from time of administration to time 48h (AUC48h) Time: 0-10 daysDescription: AUCinf will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.
Measure: Pharmacokinetics: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) Time: 0-10 daysDescription: MRT will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.
Measure: Pharmacokinetics: Mean residence time (MRT) Time: 0-10 daysDescription: t1/2 will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.
Measure: Pharmacokinetics: Elimination half-life (t1/2) Time: 0-10 daysDescription: Vd/F will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.
Measure: Pharmacokinetics: Volume of distribution (Vd/F) Time: 0-10 daysDescription: CL/F will be determined for ELX-02 and an estimation of ELX-02 dose proportionality of PK parameters.
Measure: Pharmacokinetics: Clearance (CL/F) Time: 0-10 days