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

NCT02959710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-04-11

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Cerecin

    lead INDUSTRY

Principal Investigators

  • Colleen Hunsaker, D.O. · Celerion

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
2016-11-30
Primary Completion
2017-02-28
Completion
2017-04-30

Countries

  • United States

Study Locations

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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 NCT02959710 on ClinicalTrials.gov