Phase 1 single-centre placebo- and etomidate-controlled study in healthy volunteers to assess safety, tolerability, clinical effects, and pharmacokinetics of intravenous methoxyethyl etomidate hydrochloride (ET-26)
Authors' conclusion
ET-26 was tolerated in healthy volunteers up to 2.8 mg kg-1. It produced rapid-onset, short-acting unconsciousness with stable cardiovascular and respiratory properties. Adrenocortical function was better preserved compared with etomidate 0.3 mg kg-1.
Study context
- Population
- Healthy volunteers58 stage 1a, 40 stage 1b
- Comparison
- ET-26 vs etomidate 0.3 mg kg-1
- Outcome
- Safety, hypnotic effects and adrenocortical function
Methodological detailssingle-centre, placebo-controlled, etomidate-controlled, dose-escalating, head-to-head
- Single-centre
- Placebo-controlled
- Etomidate-controlled
- Dose-escalating
- Head-to-head
Main finding
As reported in the abstract
- ET-26 produced rapid-onset, short-duration unconsciousness
- Vital signs remained stable
- Linear pharmacokinetics; two-compartment model best described pharmacokinetics
Further findings
Onset time of unconsciousness
| Outcome | ET-26 | Etomidate |
|---|---|---|
| Duration of unconsciousness | 2.9 (unspecified 0.9) | 4.8 (unspecified 1.8) |
| Area above PTC baseline after ACTH stimulation (AUCPTC) | 614 (unspecified 454) nmol h-1 | −932 (unspecified 555) nmol h-1 |
- Onset time of unconsciousness: ET-26 at effective dose (ED95) 0.8 mg kg-1
Onset time of unconsciousness
- Similar onset time
Duration of unconsciousness
- Slightly shorter duration with ET-26
Area above plasma total cortisol (PTC) baseline after ACTH stimulation (AUCPTC)
- Higher AUCPTC with ET-26
Safety
- Severe adverse events
- 0
- Myoclonus
- 53.8%
- Injection pain
- 47.4%
- Transient, resolved spontaneously
Original publication
Phase 1 single-centre placebo- and etomidate-controlled study in healthy volunteers to assess safety, tolerability, clinical effects, and pharmacokinetics of intravenous methoxyethyl etomidate hydrochloride (ET-26). Br J Anaesth. Published 29 October 2024. doi:10.
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