NCT02959710

Evaluation of PK of AC-1204 Mixed in Water, AC-1202 Mixed in Water, and AC-1202 Mixed in Ensure® on Ketone Body Production

A Phase 1, Pilot, Single-Dose, 3-Way Crossover Study to Compare the Pharmacokinetics of AC-1204 Mixed in Water, AC-1202 Mixed in Water, and AC-1202 Mixed in Ensure® on Ketone Body Production

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Cerecin · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of acetoacetate) levels after single dose administration of AC-1204 mixed in water, AC-1202 mixed in water and AC-1202 mixed in Ensure®.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AC-1204 mixed in water	40 g AC-1204 (shaken in 240 mL of water) at Hour 0 on Day 1
DRUG	AC-1202 mixed in water	60 g AC-1202 (shaken in 240 mL of water) at Hour 0 on Day 1
DRUG	AC-1202 mixed in Ensure®	60 g AC-1202 (shaken in approximately 8 oz \[237 mL of Ensure® Original\] at Hour 0 on Day 1)

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-02-01
• Completion: 2017-04-01
• First posted: 2016-11-09
• Last updated: 2017-04-11

Locations

1 site across 1 country: United States