NCT03635879

Medical Food Formulation Pharmacokinetic (PK) Study in Medium Chain Triglycerides

A Phase 1, Single-Center, Pilot, Single-Dose, 6-Way Crossover Study to Compare Six Formulations of Medium Chain Triglycerides on the Pharmacokinetics of Ketone Body Production

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cerecin · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, open label, randomized, 6-way crossover, pilot PK study

Detailed description

12 healthy, male subjects enrolled, subject will be randomized to receive a single dose of one of six treatment, with a 2 day washout in between each dosing period.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
OTHER	MCTprocal medical food	32 g MCTprocal (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
OTHER	Milk/tricaprilin oil blend	154 mL of lactose-free skim milk/21 mL of tricaprilin oil blended and then mixed in 180 mL of water at Hour 0 Day 1
OTHER	AC-1207	AC-1207 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
OTHER	AC-1205	AC-1205 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
OTHER	AC-1206	AC-1206 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
DRUG	AC-1202	AC-1202 (20 g MCT) mixed in 240 mL of water at Hour 0 Day 1

Timeline

• Start date: 2019-02-13
• Primary completion: 2019-04-16
• Completion: 2019-04-16
• First posted: 2018-08-17
• Last updated: 2018-09-27

Regulatory

• FDA-regulated drug study