NCT03063645

Study to Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 on Ketone Body Production

A Phase 1, Pilot, Single-Dose, 3-Way Crossover Study to Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 on Ketone Body Production

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Cerecin · Industry
• Sex: Male
• Age: 19 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-1202 and 2 doses of AC-SD-01.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AC-1202	60 g AC-1202 mixed in 240 mL of water at Hour 0 Day 1
DRUG	AC-SD-01 (50 g)	50 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
DRUG	AC-SD-01 (75 g)	75 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1

Timeline

• Start date: 2017-03-11
• Primary completion: 2017-04-07
• Completion: 2017-05-05
• First posted: 2017-02-24
• Last updated: 2017-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study