Trial Outcomes & Findings for Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection (NCT NCT00448227)

NCT ID: NCT00448227

Last Updated: 2011-02-11

Results Overview

Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
• Results posted on: 2011-02-11

Participant Flow

Participant milestones

Measure	Famciclovir Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

Baseline characteristics by cohort

Measure	Famciclovir n=18 Participants Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
Age Continuous	4 months STANDARD_DEVIATION 3.60 • n=5 Participants
Age, Customized 1 to <3 months	8 participants n=5 Participants
Age, Customized 3 to <6 months	5 participants n=5 Participants
Age, Customized 6 to 12 months	5 participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.

Population: Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to \<3 months age group who did not have PK samples taken due to emesis reported after study medication administration.

Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.

Outcome measures

Measure	Famciclovir: Infants 1 to <3 Months n=7 Participants Infants 1 to \<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 3 to <6 Months n=5 Participants Infants 3 to \<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 6 to 12 Months n=5 Participants Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Total
Pharmacokinetics of Single Dose - Tmax	1.00 hours Interval 1.0 to 5.17	4 hours Interval 1.0 to 4.17	1.02 hours Interval 0.58 to 1.1	—

PRIMARY outcome

Timeframe: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.

Population: Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to \<3 months age group who did not have PK samples taken due to emesis reported after study medication administration.

Measured by Cmax - The maximum plasma concentration of study medication

Outcome measures

Measure	Famciclovir: Infants 1 to <3 Months n=7 Participants Infants 1 to \<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 3 to <6 Months n=5 Participants Infants 3 to \<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 6 to 12 Months n=5 Participants Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Total
Pharmacokinetics of Single Dose - Cmax	0.69 μg/mL Standard Deviation 0.41	0.74 μg/mL Standard Deviation 0.17	3.24 μg/mL Standard Deviation 1.01	—

PRIMARY outcome

Timeframe: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.

Population: Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to \<3 months age group who did not have PK samples taken due to emesis reported after study medication administration.

Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.

Outcome measures

Measure	Famciclovir: Infants 1 to <3 Months n=7 Participants Infants 1 to \<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 3 to <6 Months n=5 Participants Infants 3 to \<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 6 to 12 Months n=5 Participants Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Total
Pharmacokinetics of Single Dose - AUC(0-tlast)	2.09 (μg/mL)•h Standard Deviation 1.38	3.16 (μg/mL)•h Standard Deviation 0.68	8.68 (μg/mL)•h Standard Deviation 2.09	—

PRIMARY outcome

Timeframe: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.

Population: Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to \<3 months age group who did not have PK samples taken due to emesis reported after study medication administration.

Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).

Outcome measures

Measure	Famciclovir: Infants 1 to <3 Months n=7 Participants Infants 1 to \<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 3 to <6 Months n=5 Participants Infants 3 to \<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 6 to 12 Months n=5 Participants Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Total
Pharmacokinetics of Single Dose - AUC(0-6h)	2.22 (μg/mL)•h Standard Deviation 1.23	3.16 (μg/mL)•h Standard Deviation 0.68	8.77 (μg/mL)•h Standard Deviation 2.14	—

SECONDARY outcome

Timeframe: 38 days

AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 days

Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 minutes after dosing

Population: Safety population.

Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:

1. Significant emesis occurred,

2. Infant spit out most of the dose ingesting less than half of what was administered,

3. Infant spit out some of the dose, but ingested at least 50% of what was administered,

4. Infant was able to ingest and retain the dose administered

Outcome measures

Measure	Famciclovir: Infants 1 to <3 Months n=8 Participants Infants 1 to \<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 3 to <6 Months n=5 Participants Infants 3 to \<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 6 to 12 Months n=5 Participants Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Total n=18 Participants
Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. Spit out some of the dose, ingested at least 50%	0 Participants	0 Participants	0 Participants	0 Participants
Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. Significant emesis occurred	1 Participants	0 Participants	0 Participants	1 Participants
Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. Spit out most of the dose, ingested less than half	0 Participants	0 Participants	0 Participants	0 Participants
Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. Able to ingest and retain dose	7 Participants	5 Participants	5 Participants	17 Participants

SECONDARY outcome

Timeframe: Immediately after dosing

Population: Safety population.

Assessed by the caregiver using a 5-point scale immediately after dosing:

1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation

2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose

3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose

4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose

5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing

Outcome measures

Measure	Famciclovir: Infants 1 to <3 Months n=8 Participants Infants 1 to \<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 3 to <6 Months n=5 Participants Infants 3 to \<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 6 to 12 Months n=5 Participants Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Total n=18 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver Very well accepted	4 Participants	3 Participants	1 Participants	8 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver Very badly / unacceptable	1 Participants	0 Participants	0 Participants	1 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver Badly but accepted	0 Participants	0 Participants	1 Participants	1 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver Neither good nor bad	0 Participants	2 Participants	1 Participants	3 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver Well accepted	2 Participants	0 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Immediately after dosing

Population: Safety population.

Assessed by the study personnel using a 5-point scale after dosing:

1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation

2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose

3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose

4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose

5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing

Outcome measures

Measure	Famciclovir: Infants 1 to <3 Months n=8 Participants Infants 1 to \<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 3 to <6 Months n=5 Participants Infants 3 to \<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Famciclovir: Infants 6 to 12 Months n=5 Participants Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.	Total n=18 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel Very badly / unacceptable	1 Participants	0 Participants	0 Participants	1 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel Badly but accepted	0 Participants	0 Participants	1 Participants	1 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel Very well accepted	4 Participants	3 Participants	1 Participants	8 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel Neither good nor bad	0 Participants	2 Participants	2 Participants	4 Participants
Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel Well accepted	2 Participants	0 Participants	1 Participants	3 Participants

Adverse Events

Famciclovir

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Famciclovir n=18 participants at risk Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
General disorders Condition aggravated	5.6% 1/18
Metabolism and nutrition disorders Dehydration	5.6% 1/18

Other adverse events

Measure	Famciclovir n=18 participants at risk Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
Blood and lymphatic system disorders Anaemia	5.6% 1/18
Ear and labyrinth disorders Hypoacusis	5.6% 1/18
Gastrointestinal disorders Diarrhoea	11.1% 2/18
Gastrointestinal disorders Vomiting	16.7% 3/18
General disorders Pyrexia	11.1% 2/18
Infections and infestations Oral candidiasis	5.6% 1/18
Investigations Occult blood positive	5.6% 1/18
Metabolism and nutrition disorders Dehydration	11.1% 2/18
Nervous system disorders Encephalitis	5.6% 1/18
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.6% 1/18
General disorders Condition aggravated	5.6% 1/18

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee There is typically a disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
• Publication restrictions are in place

Restriction type: OTHER