Who is sponsoring NCT01762995?

NCT01762995 is sponsored by ViiV Healthcare.

What drugs are being tested in NCT01762995?

Interventions in NCT01762995: Dolutegravir 50 mg, Calcium Carbonate 1200 mg, Ferrous Fumarate 324 mg.

What condition does NCT01762995 study?

NCT01762995 studies Infection, Human Immunodeficiency Virus.

Is NCT01762995 still recruiting?

NCT01762995 is currently completed. Last updated 18 April 2013.

Last reviewed 2013-04-18 · How we verify

NCT01762995

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 18 April 2013

What this trial tests

Phase 1 trial testing Dolutegravir 50 mg in Infection, Human Immunodeficiency Virus in 24 participants. Completed in 1 March 2013.

Timeline

1 December 2012

Primary endpoint
1 March 2013

1 March 2013

Quick facts

Lead sponsor	ViiV Healthcare
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 December 2012
Primary completion	1 March 2013
Estimated completion	1 March 2013

Drugs / interventions tested

Dolutegravir 50 mg — full drug profile →
Calcium Carbonate 1200 mg — full drug profile →
Ferrous Fumarate 324 mg — full drug profile →

Conditions studied

Infection, Human Immunodeficiency Virus — all drugs for Infection, Human Immunodeficiency Virus →

Sponsor

ViiV Healthcare — full company profile →

Who can join

Adults 18 to 65, any sex, with Infection, Human Immunodeficiency Virus. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Single dose plasma DTG PK assessed by AUC (0-t) and AUC (0-infinity)
Time frame: Blood samples (2 mililiter [mL]) for plasma PK parameters will be collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose), Day 2 (24 and 36 hrs post-dose) and Day 3 (48 hrs post- dose) in each of the four treatment periods
To evaluate the single dose PK of DTG, area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC \[0-t\]) and area under the concentration-time curve from time zero extrapolated to infinite time (AUC (0-infinity) will be assessed with DTG given alone and when given with Calcium Carbonate (co-administered in fed or fasted state or 2 hours (hrs) separatio
Single dose plasma DTG PK assessed by Cmax and C24
Time frame: Blood samples (2 mL) for plasma PK parameters will be collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose), day 2 (24 and 36 hrs post-dose) and day 3 (48 hrs post dose) in each of the four
To evaluate the single dose PK of DTG, maximum observed concentration (Cmax) and concentration at 24 hours post-dose (C24) will be assessed with DTG given alone and when given with Calcium Carbonate (co-administered in fed or fasted state or 2 hrs separation, fasted) or Ferrous Fumarate (co-administered in fed or fasted state or 2 hrs separation, fasted)

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Dolutegravir 50 mg

Trials testing the same drug.

NCT03851588 — Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis · Phase 2 · completed
NCT03991013 — Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial · Phase 2 · completed
NCT03360682 — Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside · Phase 4 · completed
NCT01837277 — Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients · Phase 2, PHASE3 · completed
NCT03224338 — Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects · Phase 2 · completed

Other recruiting trials for Infection, Human Immunodeficiency Virus

Currently open trials in the same condition.

NCT02951052 — Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpiv · Phase 3 · active not recruiting

Other ViiV Healthcare trials

Trials by the same sponsor.

NCT07393659 — A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative · Phase 3 · not yet recruiting
NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 · Phase 1, PHASE2 · not yet recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT07053384 — A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Vir · Phase 1 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01762995 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ViiV Healthcare
Last refreshed: 18 April 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01762995.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing