SNPMiner Trials by Shray Alag


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Report for Mutation T1095C

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 ---

Primary Outcomes

Description: Incidence and characteristics of adverse events occurring following single doses of ELX-02

Measure: Adverse Events

Time: 0-10 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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


HPO Nodes