Trial Outcomes & Findings for Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117) (NCT NCT02387983)

NCT ID: NCT02387983

Last Updated: 2018-10-09

Results Overview

The ssCavg was calculated in order to determine the percentage of participants achieving the pharmacokinetic (PK) target of ssCavg \>500 ng/mL on Day 8 when plasma drug levels had reached steady state.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 65 participants
• Primary outcome timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8
• Results posted on: 2018-10-09

Participant Flow

Adult (18 to 70 years of age) male and female participants with neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) were recruited at 4 sites in China.

Participant milestones

Measure	Posaconazole All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Overall Study STARTED	65
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Posaconazole All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Overall Study Adverse Event	4
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)

Baseline characteristics by cohort

Measure	Posaconazole n=65 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Age, Continuous	42.7 Years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8

Population: The PK analysis set included all randomized and treated participants who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation and have data available.

The ssCavg was calculated in order to determine the percentage of participants achieving the pharmacokinetic (PK) target of ssCavg >500 ng/mL on Day 8 when plasma drug levels had reached steady state.

Outcome measures

Measure	Posaconazole n=44 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8 ssCavg < 500 ng/mL	0.0 Percentage of Participants
Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8 500 ng/mL ≤ ssCavg < 2500 ng/mL	88.9 Percentage of Participants
Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8 2500 ng/mL ≤ ssCavg < 3750 ng/mL	11.1 Percentage of Participants
Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8 ssCavg ≥ 3750 ng/mL	0 Percentage of Participants

PRIMARY outcome

Timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8

Population: The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation and have data available.

The ssAUC0-24hr was calculated to determine the mean plasma drug concentration in the Intensive and Sparse PK subgroup from immediately after dosing to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).

Outcome measures

Measure	Posaconazole n=18 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of Posaconazole on Day 8	38600 hr*ng/mL Standard Deviation 42.8

PRIMARY outcome

Timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8

Population: The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.

The ssCmax was calculated in order to determine the maximum post-dose plasma drug concentration in the Intensive and Sparse PK subgroup on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).

Outcome measures

Measure	Posaconazole n=18 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Steady-state Maximum Concentration (ssCmax) of Posaconazole on Day 8	2150 ng/mL Standard Deviation 43.9

PRIMARY outcome

Timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8

Population: The PK analysis set included all randomized and treated participants in the Intensive and Sparse subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.

The ssCmin was calculated in order to determine the lowest measurable drug concentration in the Intensive and Sparse PK subgroup up to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).

Outcome measures

Measure	Posaconazole n=18 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Steady-state Minimum Concentration (ssCmin) of Posaconazole on Day 8	1310 ng/mL Standard Deviation 43.6

PRIMARY outcome

Timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8

Population: The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.

The ssTmax was calculated in order to determine the amount of time required to reach ssCmax in the Intensive and Sparse PK subgroup on Day 8.

Outcome measures

Measure	Posaconazole n=18 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Time to Steady-state Maximum Concentration (ssTmax) of Posaconazole on Day 8	4.04 hr Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1

Population: The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.

The AUC0-24hr was calculated to determine the mean plasma drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).

Outcome measures

Measure	Posaconazole n=20 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
AUC0-24hr of Posaconazole on Day 1	14500 hr*ng/mL Standard Deviation 39.0

PRIMARY outcome

Timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1

Population: The PK analysis set included all randomized and treated participants in the Immediate and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.

The Cmax was calculated to determine the maximum plasma drug concentration up to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).

Outcome measures

Measure	Posaconazole n=20 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Cmax of Posaconazole on Day 1	730 ng/mL Standard Deviation 47.7

PRIMARY outcome

Timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1

Population: The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.

The Cmin was calculated in order to determine the lowest measurable drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).

Outcome measures

Measure	Posaconazole n=20 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Cmin of Posaconazole on Day 1	997 ng/mL Standard Deviation 35.9

PRIMARY outcome

Timeframe: Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1

Population: The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.

The Tmax was calculated in order to determine the time required to reach Cmax in the Immediate and Sparse PK subgroup on Day 1.

Outcome measures

Measure	Posaconazole n=20 Participants All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse PK subgroup) underwent intensive and sparse pharmacokinetic (PK) sampling on Days 1 and 8; the next 45 participants (Sparse PK subgroup) underwent PK sampling on Day 8 only.
Tmax of Posaconazole on Day 1	3.99 Hours Interval 1.97 to 7.98

Adverse Events

MK-5592

Serious events: 4 serious events

Other events: 64 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK-5592 n=65 participants at risk All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse group) underwent intensive and sparse PK sampling on Days 1 and 8; the next 45 participants (Sparse group) underwent PK sampling on Day 8 only.
Nervous system disorders Haemorrhage intracranial	1.5% 1/65 • Number of events 1 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.5% 1/65 • Number of events 1 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Infections and infestations Anal infection	1.5% 1/65 • Number of events 1 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Infections and infestations Lung infection	1.5% 1/65 • Number of events 1 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Other adverse events

Measure	MK-5592 n=65 participants at risk All participants received posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28. The first 20 participants (Intensive and Sparse group) underwent intensive and sparse PK sampling on Days 1 and 8; the next 45 participants (Sparse group) underwent PK sampling on Day 8 only.
Blood and lymphatic system disorders Anaemia	9.2% 6/65 • Number of events 16 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Blood and lymphatic system disorders Leukopenia	16.9% 11/65 • Number of events 14 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Blood and lymphatic system disorders Thrombocytopenia	18.5% 12/65 • Number of events 32 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Gastrointestinal disorders Abdominal discomfort	6.2% 4/65 • Number of events 5 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Gastrointestinal disorders Abdominal distension	9.2% 6/65 • Number of events 7 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Gastrointestinal disorders Abdominal pain	7.7% 5/65 • Number of events 5 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Gastrointestinal disorders Constipation	7.7% 5/65 • Number of events 5 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Gastrointestinal disorders Diarrhoea	33.8% 22/65 • Number of events 25 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Gastrointestinal disorders Faeces hard	6.2% 4/65 • Number of events 4 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Gastrointestinal disorders Mouth ulceration	10.8% 7/65 • Number of events 10 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Gastrointestinal disorders Nausea	12.3% 8/65 • Number of events 10 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Gastrointestinal disorders Vomiting	6.2% 4/65 • Number of events 4 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
General disorders Asthenia	9.2% 6/65 • Number of events 7 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
General disorders Chest discomfort	7.7% 5/65 • Number of events 5 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
General disorders Oedema peripheral	15.4% 10/65 • Number of events 13 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
General disorders Pyrexia	53.8% 35/65 • Number of events 59 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Infections and infestations Febrile infection	9.2% 6/65 • Number of events 8 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Infections and infestations Lung infection	16.9% 11/65 • Number of events 12 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Infections and infestations Soft tissue infection	7.7% 5/65 • Number of events 7 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Injury, poisoning and procedural complications Transfusion related complication	7.7% 5/65 • Number of events 10 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Investigations Alanine aminotransferase increased	18.5% 12/65 • Number of events 12 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Investigations Aspartate aminotransferase increased	12.3% 8/65 • Number of events 8 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Investigations Blood bilirubin increased	21.5% 14/65 • Number of events 17 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	12.3% 8/65 • Number of events 8 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Metabolism and nutrition disorders Hypocalcaemia	23.1% 15/65 • Number of events 19 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Metabolism and nutrition disorders Hypokalaemia	38.5% 25/65 • Number of events 32 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Metabolism and nutrition disorders Hypoproteinaemia	15.4% 10/65 • Number of events 11 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Nervous system disorders Dizziness	7.7% 5/65 • Number of events 6 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Psychiatric disorders Insomnia	6.2% 4/65 • Number of events 5 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Renal and urinary disorders Haematuria	10.8% 7/65 • Number of events 7 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Cough	23.1% 15/65 • Number of events 17 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	6.2% 4/65 • Number of events 4 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.7% 5/65 • Number of events 6 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Skin and subcutaneous tissue disorders Rash	21.5% 14/65 • Number of events 21 • Up to Day 42 An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
• Publication restrictions are in place

Restriction type: OTHER