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

NCT03063645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-06-27

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-1202 and 2 doses of AC-SD-01.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Cerecin

    lead INDUSTRY

Principal Investigators

  • Charles Tomek, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-03-11
Primary Completion
2017-04-07
Completion
2017-05-05
FDA Drug
Yes

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 NCT03063645 on ClinicalTrials.gov