Trial Outcomes & Findings for A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis. (NCT NCT00377741)
NCT ID: NCT00377741
Last Updated: 2015-12-31
Results Overview
The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC \[0-tau\]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose
Results posted on
2015-12-31
Participant Flow
A total of 31 participants were included from 5 centers in the United States of America. This study was conducted between 01 December 2004 and 30 June 2006.
Participants were received 900 mg of commercial medication of valganciclovir tablet daily for \>= 4 days prior to study Day 1 so as to achieve steady-state kinetics of ganciclovir.
Participant milestones
| Measure |
Cystic Fibrosis (CF)
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
|
Non-Cystic Fibrosis (Non-CF)
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
Baseline characteristics by cohort
| Measure |
Cystic Fibrosis (CF)
n=16 Participants
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
|
Non-Cystic Fibrosis (Non-CF)
n=15 Participants
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.8 Years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
51.6 Years
STANDARD_DEVIATION 8.66 • n=7 Participants
|
40.4 Years
STANDARD_DEVIATION 14.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dosePopulation: The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC \[0-tau\]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.
Outcome measures
| Measure |
Cystic Fibrosis (CF)
n=16 Participants
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
|
Non-Cystic Fibrosis (Non-CF)
n=15 Participants
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
|
|---|---|---|
|
Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)
|
66.2 h*mcg/mL
Standard Deviation 31.3
|
54.1 h*mcg/mL
Standard Deviation 16.6
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dosePopulation: The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.
Outcome measures
| Measure |
Cystic Fibrosis (CF)
n=16 Participants
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
|
Non-Cystic Fibrosis (Non-CF)
n=15 Participants
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ganciclovir
|
8.46 μg/mL
Standard Deviation 3.16
|
7.54 μg/mL
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dosePopulation: The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
The Tmax is defined as time to reach maximum observed Ganciclovir concentration. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.
Outcome measures
| Measure |
Cystic Fibrosis (CF)
n=16 Participants
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
|
Non-Cystic Fibrosis (Non-CF)
n=15 Participants
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
|
|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir
|
1.99 h
Interval 1.0 to 4.07
|
1.98 h
Interval 0.92 to 5.97
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dosePopulation: The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
The apparent elimination rate is equal to the magnitude of the slope from the log-linear regression of plasma concentration versus time over the interval t to 24, where t is the first time-point used for this regression. Kelim was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.
Outcome measures
| Measure |
Cystic Fibrosis (CF)
n=16 Participants
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
|
Non-Cystic Fibrosis (Non-CF)
n=15 Participants
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
|
|---|---|---|
|
Apparent Elimination Rate (Kelim) of Ganciclovir
|
4.43 1/h
Standard Deviation 0.745
|
4.91 1/h
Standard Deviation 0.684
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dosePopulation: The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.
Plasma half-life is the time measured for the plasma concentration to decrease by one half. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1. T1/2 was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.
Outcome measures
| Measure |
Cystic Fibrosis (CF)
n=16 Participants
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
|
Non-Cystic Fibrosis (Non-CF)
n=15 Participants
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
|
|---|---|---|
|
Plasma Half-Life (T1/2) of Ganciclovir
|
4.43 h
Standard Deviation 0.75
|
4.91 h
Standard Deviation 0.68
|
Adverse Events
Cystic Fibrosis (CF)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Non-Cystic Fibrosis (Non-CF)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cystic Fibrosis (CF)
n=16 participants at risk
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
|
Non-Cystic Fibrosis (Non-CF)
n=15 participants at risk；n=16 participants at risk
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
General disorders
Chills
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
Other adverse events
| Measure |
Cystic Fibrosis (CF)
n=16 participants at risk
Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
|
Non-Cystic Fibrosis (Non-CF)
n=15 participants at risk；n=16 participants at risk
Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.7%
1/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.7%
1/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.7%
1/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.7%
1/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
13.3%
2/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.7%
1/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.7%
1/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.7%
1/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.7%
1/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Immune system disorders
Transplant Rejection
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Investigations
Pulmonary Function Test Decreased
|
6.2%
1/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
0.00%
0/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
6.7%
1/15 • Up to 4 Weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all patients who were enrolled on the study and had at least one safety assessment, whether withdrawn prematurely or no were included in the safety analysis.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER