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2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT01762995
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2012-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of Calcium Carbonate and Ferrous Fumarate on Pharmacokinetics of Dolutegravir in Healthy Adult Subjects
Sponsor:
ViiV Healthcare
Organization:
Study Overview
Official Title:
A Phase I, Open Label, Randomized, Four-Period Crossover Study to Evaluate the Effects of Calcium Carbonate 1200 mg and Ferrous Fumarate 324 mg on Pharmacokinetics of Dolutegravir 50 mg in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Human immune virus (HIV) infected subjects may take mineral supplements in combination with their antiretroviral medications. Calcium and Iron supplementations are commonly used and both of these have the potential to interact with Dolutegravir (DTG), this study will evaluate the potential of calcium and iron supplements to decrease DTG exposure. It will also evaluate two possible strategies for combined use; if an interaction is observed. The first strategy is a two hour separation. The second strategy involves the administration of DTG and the supplement with a meal since the presence of food modestly increases DTG exposure, and because mineral supplements can be administered with food.
This is an open label, randomized, two cohort, four-period cross-over study in healthy volunteers. One cohort will examine the effects of calcium carbonate and the other cohort will examine the effects of ferrous fumarate on the pharmacokinetic (PK) of DTG. Approximately 12 subjects will be enrolled into each of the two cohorts and receive each of four treatments in a randomized fashion: 1) A single dose of DTG 50 milligram (mg) administered under fasted conditions ; 2) A single dose of DTG 50 mg co-administered with a single dose of calcium carbonate or ferrous fumarate under fasted conditions ; 3) A single dose of DTG 50 mg co-administered with a single dose of calcium carbonate or ferrous fumarate with a moderate-fat meal; 4) A single dose of DTG 50 mg administered under fasted conditions 2 hours prior to administration of a single dose of calcium carbonate or ferrous fumarate. There will be a washout period of at least 7 days between treatments. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug. This study will be conducted at one center in the United States, with healthy adult male and female subjects.
This is an open label, randomized, two cohort, four-period cross-over study in healthy volunteers. One cohort will examine the effects of calcium carbonate and the other cohort will examine the effects of ferrous fumarate on the pharmacokinetic (PK) of DTG. Approximately 12 subjects will be enrolled into each of the two cohorts and receive each of four treatments in a randomized fashion: 1) A single dose of DTG 50 milligram (mg) administered under fasted conditions ; 2) A single dose of DTG 50 mg co-administered with a single dose of calcium carbonate or ferrous fumarate under fasted conditions ; 3) A single dose of DTG 50 mg co-administered with a single dose of calcium carbonate or ferrous fumarate with a moderate-fat meal; 4) A single dose of DTG 50 mg administered under fasted conditions 2 hours prior to administration of a single dose of calcium carbonate or ferrous fumarate. There will be a washout period of at least 7 days between treatments. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug. This study will be conducted at one center in the United States, with healthy adult male and female subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: