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

NCT03635879 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-09-27

No results posted yet for this study

Summary

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

Conditions

  • Alzheimer Disease

Interventions

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

Sponsors & Collaborators

  • Cerecin

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2019-04-16
Completion
2019-04-16
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635879 on ClinicalTrials.gov