Trial · NCT01716234

A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)

NCT01716234, Phase 1, Terminated, Merck Sharp & Dohme LLC; results first posted 2016-04-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579). Trials, record NCT01716234. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01716234

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
NCT number: NCT01716234
Status: Terminated
Phases: Phase 1
Enrollment: 142 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Fungal Infections
Interventions: Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID, Posaconazole 18 mg/kg/day TID, Posaconazole 12 mg/kg/day TID
First posted: 2012-10-29
Last updated: 2018-08-27
Other registries' IDs: eudract:2007-004645-15
Results first posted: 2016-04-15
Limitations and caveats: Only 1 participant was enrolled in the POS 12 TID 3 months to \<2 years group, limiting conclusions that may be drawn for pharmacokinetics or safety.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)	Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to \<2 years of age weighing \<6.5 kg.
Primary	Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)	Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose	Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to \<2500 ng/mL.
Secondary	Number of Participants With an Adverse Event	Up to Day 58	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
Secondary	Number of Participants With an Adverse Event Leading to Study Drug Discontinuation	Up to Day 28	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)	The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.	ng/mL	MEAN
PRIMARY	Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)	Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose	The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.	ng/mL	MEAN
SECONDARY	Number of Participants With an Adverse Event	Up to Day 58	The population analyzed was all treated participants.	Participants	NUMBER
SECONDARY	Number of Participants With an Adverse Event Leading to Study Drug Discontinuation	Up to Day 28	The population analyzed was all treated participants.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	POS 12 BID 2 to <7 Years	122	Standard Deviation 101	ng/mL
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	POS 12 BID 7 to <18 Years	107	Standard Deviation 92.5	ng/mL
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	POS 18 BID 2 to <7 Years	112	Standard Deviation 86.9	ng/mL
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	POS 18 BID 7 to <18 Years	113	Standard Deviation 100	ng/mL
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	POS 18 TID 2 to <7 Years	68.4	Standard Deviation 40.4	ng/mL
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	POS 18 TID 7 to <18 Years	57.9	Standard Deviation 30.2	ng/mL
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)	POS 12 TID 3 Months to <2 Years	68.5	Standard Deviation 0	ng/mL
Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)	POS 12 BID 2 to <7 Years	604	Standard Deviation 779	ng/mL
Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)	POS 12 BID 7 to <18 Years	1050	Standard Deviation 789	ng/mL
Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)	POS 18 BID 2 to <7 Years	485	Standard Deviation 306	ng/mL

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow28

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	POS 12 BID 2 to <7 Years	24
Overall Study	STARTED	POS 12 BID 7 to <18 Years	22
Overall Study	STARTED	POS 18 BID 2 to <7 Years	20
Overall Study	STARTED	POS 18 BID 7 to <18 Years	28
Overall Study	STARTED	POS 18 TID 2 to <7 Years	15
Overall Study	STARTED	POS 18 TID 7 to <18 Years	32
Overall Study	STARTED	POS 12 TID 3 Months to <2 Years	1
Overall Study	Treated	POS 12 BID 2 to <7 Years	22
Overall Study	Treated	POS 12 BID 7 to <18 Years	21
Overall Study	Treated	POS 18 BID 2 to <7 Years	19

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events1,246

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	POS 12 BID 2 to <7 Yrs	4	22	6
other	Anaemia	Blood and lymphatic system disorders	POS 12 BID 7 to <18 Yrs	2	21	3
other	Anaemia	Blood and lymphatic system disorders	POS 18 BID 2 to <7 Yrs	3	19	6
other	Anaemia	Blood and lymphatic system disorders	POS 18 BID 7 to <18 Yrs	8	28	12
other	Anaemia	Blood and lymphatic system disorders	POS 18 TID 2 to <7 Yrs	3	15	11
other	Anaemia	Blood and lymphatic system disorders	POS 18 TID 7 to <18 Yrs	6	30	12
other	Anaemia	Blood and lymphatic system disorders	POS 12 TID 3 Months to <2 Yrs	0	1	0
other	Coagulopathy	Blood and lymphatic system disorders	POS 12 BID 2 to <7 Yrs	0	22	0
other	Coagulopathy	Blood and lymphatic system disorders	POS 12 BID 7 to <18 Yrs	0	21	0
other	Coagulopathy	Blood and lymphatic system disorders	POS 18 BID 2 to <7 Yrs	0	19	0

1 to 10 of 1,246Source ClinicalTrials.gov

See all 1,246 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	POS 12 BID 2 to <7 Yrs
Total, all-cause mortality	POS 12 BID 7 to <18 Yrs
Total, all-cause mortality	POS 18 BID 2 to <7 Yrs
Total, all-cause mortality	POS 18 BID 7 to <18 Yrs
Total, all-cause mortality	POS 18 TID 2 to <7 Yrs
Total, all-cause mortality	POS 18 TID 7 to <18 Yrs
Total, all-cause mortality	POS 12 TID 3 Months to <2 Yrs
Total, other adverse events	POS 12 BID 2 to <7 Yrs	21	22
Total, other adverse events	POS 12 BID 7 to <18 Yrs	20	21
Total, other adverse events	POS 18 BID 2 to <7 Yrs	16	19

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30913226	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01716234

GET https://conductscience.org/api/trials/v1/NCT01716234/results?page=2

API reference For AI assistants