Trial Outcomes & Findings for Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults (NCT NCT00914862)
NCT ID: NCT00914862
Last Updated: 2012-04-04
Results Overview
Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.
Results posted on
2012-04-04
Participant Flow
Participants took part in the study at one investigative site in the United States from 02 November 2009 to 03 April 2011.
Participants were enrolled into one of five treatment groups by age and assigned to either 4 mg or 8 mg ramelteon.
Participant milestones
| Measure |
Children Ramelteon 4 mg
Children 6 to 11 years of age who had insomnia associated with Attention Deficit Hyperactivity Disorder (ADHD) received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
8
|
8
|
28
|
|
Overall Study
COMPLETED
|
6
|
6
|
8
|
8
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults
Baseline characteristics by cohort
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
7.8 years
STANDARD_DEVIATION 1.72 • n=5 Participants
|
9.2 years
STANDARD_DEVIATION 1.47 • n=7 Participants
|
15.8 years
STANDARD_DEVIATION 1.67 • n=5 Participants
|
15.5 years
STANDARD_DEVIATION 1.93 • n=4 Participants
|
30.9 years
STANDARD_DEVIATION 10.17 • n=21 Participants
|
21.7 years
STANDARD_DEVIATION 12.00 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
54 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
9 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
23 participants
n=21 Participants
|
45 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
28 participants
n=21 Participants
|
56 participants
n=8 Participants
|
|
Weight
|
28.1 kg
STANDARD_DEVIATION 7.40 • n=5 Participants
|
36.6 kg
STANDARD_DEVIATION 12.24 • n=7 Participants
|
61.4 kg
STANDARD_DEVIATION 11.14 • n=5 Participants
|
66.4 kg
STANDARD_DEVIATION 12.99 • n=4 Participants
|
76.8 kg
STANDARD_DEVIATION 13.85 • n=21 Participants
|
63.6 kg
STANDARD_DEVIATION 21.40 • n=8 Participants
|
|
Height
|
128 cm
STANDARD_DEVIATION 11.8 • n=5 Participants
|
141 cm
STANDARD_DEVIATION 11.9 • n=7 Participants
|
168 cm
STANDARD_DEVIATION 11.2 • n=5 Participants
|
170 cm
STANDARD_DEVIATION 12.8 • n=4 Participants
|
174 cm
STANDARD_DEVIATION 11.7 • n=21 Participants
|
164 cm
STANDARD_DEVIATION 19.5 • n=8 Participants
|
|
Body Mass Index (BMI)
|
16.5 kg/m^2
STANDARD_DEVIATION 2.19 • n=5 Participants
|
17.6 kg/m^2
STANDARD_DEVIATION 3.75 • n=7 Participants
|
21.7 kg/m^2
STANDARD_DEVIATION 2.53 • n=5 Participants
|
22.9 kg/m^2
STANDARD_DEVIATION 2.94 • n=4 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 3.05 • n=21 Participants
|
22.6 kg/m^2
STANDARD_DEVIATION 4.29 • n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.Population: The Pharmacokinetic (PK) set, which consisted of all patients who received study drug and had sufficient concentration data to calculate at least 1 PK parameter.
Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
M-II (n=6, n=6, n=8, n=8, n=28)
|
52.5 ng/mL
Standard Deviation 21.83
|
79.0 ng/mL
Standard Deviation 56.94
|
21.5 ng/mL
Standard Deviation 6.54
|
39.6 ng/mL
Standard Deviation 7.63
|
40.8 ng/mL
Standard Deviation 14.53
|
|
Maximum Observed Serum Concentration (Cmax)
Ramelteon (n=6, n=6, n=8, n=8, n=28)
|
0.702 ng/mL
Standard Deviation 0.8145
|
0.998 ng/mL
Standard Deviation 1.0106
|
0.413 ng/mL
Standard Deviation 0.4310
|
0.759 ng/mL
Standard Deviation 0.5112
|
1.681 ng/mL
Standard Deviation 2.3822
|
PRIMARY outcome
Timeframe: Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.Population: Pharmacokinetic set where valid PK parameter estimates were available.
Tmax: Time to reach the maximum serum concentration (Cmax) of ramelteon and its metabolite M-II, equal to time (hours) to Cmax.
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Serum Concentration (Tmax)
Ramelteon (n=6, n=6, n=7, n=8, n=28)
|
0.50 hours
Interval 0.5 to 2.0
|
0.50 hours
Interval 0.5 to 2.0
|
2.00 hours
Interval 0.5 to 3.0
|
1.00 hours
Interval 0.5 to 2.0
|
1.00 hours
Interval 0.5 to 3.0
|
|
Time to Reach Maximum Serum Concentration (Tmax)
M-II (n=6, n=6, n=8, n=8, n=28)
|
0.75 hours
Interval 0.5 to 2.0
|
1.00 hours
Interval 0.5 to 2.0
|
2.00 hours
Interval 1.0 to 8.0
|
2.00 hours
Interval 0.5 to 2.0
|
2.00 hours
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.Population: Pharmacokinetic set where valid PK parameter estimates were available.
Area under the serum concentration-time curve from time 0 to time of last quantifiable concentration (tlqc) of ramelteon and its metabolite M-II, calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc])
Ramelteon (n=6, n=6, n=8, n=8, n=28)
|
0.703 ng*hr/mL
Standard Deviation 0.7098
|
1.353 ng*hr/mL
Standard Deviation 1.0621
|
1.022 ng*hr/mL
Standard Deviation 0.9553
|
1.564 ng*hr/mL
Standard Deviation 1.0591
|
3.636 ng*hr/mL
Standard Deviation 3.9104
|
|
Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc])
M-II (n=6, n=6, n=8, n=8, n=28)
|
127.2 ng*hr/mL
Standard Deviation 57.81
|
223.4 ng*hr/mL
Standard Deviation 61.84
|
88.8 ng*hr/mL
Standard Deviation 41.43
|
175.4 ng*hr/mL
Standard Deviation 43.39
|
190.6 ng*hr/mL
Standard Deviation 62.95
|
PRIMARY outcome
Timeframe: Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.Population: Pharmacokinetic set where valid PK parameter estimates were available.
Area under the serum concentration-time curve from time zero extrapolated to infinity for ramelteon and its metabolite M-II. The terminal area from the last quantifiable concentration (lqc) to infinity is calculated by approximation: lqc / terminal elimination rate constant (λz).
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=7 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC[0-inf])
Ramelteon (n=4, n=5, n=4, n=8, n=25)
|
1.03 ng*hr/mL
Standard Deviation 0.740
|
1.65 ng*hr/mL
Standard Deviation 1.104
|
1.75 ng*hr/mL
Standard Deviation 0.812
|
1.69 ng*hr/mL
Standard Deviation 1.051
|
4.22 ng*hr/mL
Standard Deviation 3.986
|
|
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC[0-inf])
M-II (n=6, n=6, n=8, n=8, n=28)
|
131.0 ng*hr/mL
Standard Deviation 59.67
|
227.6 ng*hr/mL
Standard Deviation 62.57
|
92.4 ng*hr/mL
Standard Deviation 43.68
|
179.2 ng*hr/mL
Standard Deviation 43.81
|
195.4 ng*hr/mL
Standard Deviation 65.06
|
PRIMARY outcome
Timeframe: Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.Population: Pharmacokinetic set where valid PK parameter estimates were available.
Apparent oral clearance of drug from the serum calculated as: CL/F = Dose / Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC\[0-inf\]).
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=4 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=5 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=4 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=25 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Apparent Clearance After Oral Administration (CL/F)
|
5374 L/hr
Standard Deviation 3117.6
|
6883 L/hr
Standard Deviation 4112.3
|
2605 L/hr
Standard Deviation 931.5
|
7319 L/hr
Standard Deviation 5426.6
|
4086 L/hr
Standard Deviation 3793.6
|
PRIMARY outcome
Timeframe: Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.Population: Pharmacokinetic set where valid PK parameter estimates were available.
The rate at which ramelteon and its metabolite M-II are eliminated from the body, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Terminal Elimination Rate Constant (λz)
Ramelteon (n=4, n=5, n=4, n=8, n=25)
|
0.743 1/hour
Standard Deviation 0.2181
|
0.659 1/hour
Standard Deviation 0.07205
|
0.550 1/hour
Standard Deviation 0.1358
|
0.541 1/hour
Standard Deviation 0.1651
|
0.483 1/hour
Standard Deviation 0.1234
|
|
Terminal Elimination Rate Constant (λz)
M-II (n=6, n=6, n=8, n=8, n=28)
|
0.436 1/hour
Standard Deviation 0.1109
|
0.363 1/hour
Standard Deviation 0.0771
|
0.377 1/hour
Standard Deviation 0.1217
|
0.331 1/hour
Standard Deviation 0.0936
|
0.278 1/hour
Standard Deviation 0.0400
|
PRIMARY outcome
Timeframe: Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.Population: Pharmacokinetic set where valid PK parameter estimates were available.
Terminal phase elimination half-life (T1/2) for ramelteon and its metabolite M-II is the time required for half of the drug to be eliminated from the serum, calculated as T1/2 = natural logarithm of 2 (ln\[2\]) / Terminal elimination rate constant (λz).
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half-life (T1/2)
Ramelteon (n=4, n=5, n=4, n=8, n=25)
|
1.02 hours
Standard Deviation 0.399
|
1.06 hours
Standard Deviation 0.117
|
1.32 hours
Standard Deviation 0.343
|
1.41 hours
Standard Deviation 0.490
|
1.52 hours
Standard Deviation 0.341
|
|
Terminal Elimination Half-life (T1/2)
M-II (n=6, n=6, n=8, n=8, n=28)
|
1.72 hours
Standard Deviation 0.635
|
1.98 hours
Standard Deviation 0.383
|
1.99 hours
Standard Deviation 0.536
|
2.21 hours
Standard Deviation 0.454
|
2.55 hours
Standard Deviation 0.385
|
PRIMARY outcome
Timeframe: Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.Population: Pharmacokinetic set where valid PK parameter estimates were available.
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as Vz/F = Apparent oral clearance (CL/F) / Terminal elimination rate constant (λz).
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=4 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=5 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=4 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=25 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
9136 Liters
Standard Deviation 8703.1
|
10912 Liters
Standard Deviation 6923.3
|
5016 Liters
Standard Deviation 2462.4
|
14294 Liters
Standard Deviation 10591.2
|
8606 Liters
Standard Deviation 8417.1
|
SECONDARY outcome
Timeframe: Day 1 to Day 15Population: The safety set includes all participants who received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. The different categories of intensity (severity) were characterized as follows: Mild: The event was transient and easily tolerated by the participant. Moderate: The event causes the participant discomfort and interrupted usual activities. Severe: The event causes considerable interference with the participant's usual activities.
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE)
Any AE
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AE)
Mild AE
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AE)
Moderate AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AE)
Severe AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE)
Leading to discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening, Day 1, Day 2 and Day 4Population: Safety set.
Laboratory samples were collected at Screening, Check-in (Day 1), and Day 2 or Early Termination for assessment of hematology, chemistry, and urinalysis.
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Findings
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening, Day 1, Day 2 and Day 4Population: Safety set.
Vital signs included oral body temperature, pulse and blood pressure (taken after 5 minutes in the sitting position). Vital signs measurements were determined to be clinically significant according to predefined criteria.
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening, Day 2 and Day 4Population: Safety set.
A standard 12-lead electrocardiogram (ECG) was recorded at Screening, Day 2, and at Final Visit (Day 4). The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram Findings
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening, Day 1, Day 2 and Day 4Population: Safety set.
A complete physical examination was performed for each participant at Screening, Check-in (Day 1), Day 2, and Final Visit (Day 4) or Early Termination. The examination consisted of a review of the following body systems: eyes; ears, nose, and throat; respiratory; gastrointestinal; extremities; musculoskeletal; cardiovascular; nervous; and dermatological.
Outcome measures
| Measure |
Children Ramelteon 4 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 Participants
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 Participants
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 Participants
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examination Results
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
Adverse Events
Children Ramelteon 4 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Children Ramelteon 8 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Adolescents Ramelteon 4 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Adolescents Ramelteon 8 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Adult Ramelteon 8 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Children Ramelteon 4 mg
n=6 participants at risk
Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
|
Children Ramelteon 8 mg
n=6 participants at risk
Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
|
Adolescents Ramelteon 4 mg
n=8 participants at risk
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
|
Adolescents Ramelteon 8 mg
n=8 participants at risk
Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
|
Healthy Adult Ramelteon 8 mg
n=28 participants at risk
Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Day 1 to Day 15.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER