NCT00901823

Brief Summary

This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

May 12, 2009

Last Update Submit

August 30, 2016

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR

    35 days

Secondary Outcomes (1)

  • Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions

    35 days

Study Arms (2)

Sequence 1

EXPERIMENTAL

Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR

Drug: Diazoxide choline

Sequence 2

EXPERIMENTAL

Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR

Drug: Diazoxide choline high dose

Interventions

Diazoxide cholineDRUG

A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR

Sequence 1
Diazoxide choline high doseDRUG

A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR

Sequence 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Healthy adults
  • Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
  • Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL

You may not qualify if:

  • Known CAD, DM, uncontrolled HTN
  • Pregnancy or unable to complaint with the birth control method required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 14, 2009

Study Start

March 1, 2011

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 1, 2016

Record last verified: 2016-08