Trial Outcomes & Findings for A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED) (NCT NCT00979459)
NCT ID: NCT00979459
Last Updated: 2016-02-05
Results Overview
AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
Results posted on
2016-02-05
Participant Flow
Participant milestones
| Measure |
MK-1006 DFC, Then MK-1006 FCT
Participants received a single dose of four 20 mg MK-1006 dry filled capsules (DFC) followed by a single dose of two 40 mg MK-1006 film coated tablets (FCT) after a 7 day washout period.
|
MK-1006 FCT, Then MK-1006 DFC
Participants received a single dose of two 40 mg film coated tablets (FCT) of MK-1006 followed by a single dose of four 20 mg MK-1006 dry filled capsules (DFC) after a 7 day washout period.
|
|---|---|---|
|
First Intervention
STARTED
|
6
|
6
|
|
First Intervention
COMPLETED
|
6
|
6
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
7-day Washout Period
STARTED
|
6
|
6
|
|
7-day Washout Period
COMPLETED
|
6
|
6
|
|
7-day Washout Period
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
6
|
6
|
|
Second Intervention
COMPLETED
|
6
|
6
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
Includes participants who were randomized to receive either a single dose of four 20 mg MK-1006 DFC followed by a single dose of two 40 mg MK-1006 FCT or a single dose of four 20 mg MK-1006 FCT followed by a single dose of two 40 mg MK-1006 DFC
|
|---|---|
|
Age, Customized
<35 years
|
0 participants
n=99 Participants
|
|
Age, Customized
Between 35 and 65 years
|
12 participants
n=99 Participants
|
|
Age, Customized
>65 years
|
0 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-doseAUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC
Outcome measures
| Measure |
MK-1006 80 mg FCT
n=12 Participants
Participants received a single dose of two MK-1006 40 mg FCT
|
MK-1006 80 mg DFC
n=12 Participants
Participants received a single dose of four MK-1006 20 mg DFC
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006
|
5171 nM*hr
Interval 4350.0 to 6147.0
|
5588 nM*hr
Interval 4593.0 to 6798.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-doseMaximum plasma concentration for 2 formulations of MK-1006, FCT and DFC
Outcome measures
| Measure |
MK-1006 80 mg FCT
n=12 Participants
Participants received a single dose of two MK-1006 40 mg FCT
|
MK-1006 80 mg DFC
n=12 Participants
Participants received a single dose of four MK-1006 20 mg DFC
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) for MK-1006
|
554 nM
Interval 429.0 to 715.0
|
519 nM
Interval 405.0 to 664.0
|
SECONDARY outcome
Timeframe: Through 30 days post-dosePopulation: All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.
Outcome measures
| Measure |
MK-1006 80 mg FCT
n=12 Participants
Participants received a single dose of two MK-1006 40 mg FCT
|
MK-1006 80 mg DFC
n=12 Participants
Participants received a single dose of four MK-1006 20 mg DFC
|
|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: up to 8 daysPopulation: All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.
Outcome measures
| Measure |
MK-1006 80 mg FCT
n=12 Participants
Participants received a single dose of two MK-1006 40 mg FCT
|
MK-1006 80 mg DFC
n=12 Participants
Participants received a single dose of four MK-1006 20 mg DFC
|
|---|---|---|
|
Number of Participants Who Discontinued Study Medication Due to an Adverse Event
|
0 participants
|
0 participants
|
Adverse Events
MK-1006 80 mg FCT
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MK-1006 80 mg DFC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-1006 80 mg FCT
n=12 participants at risk
Participants received a single dose of two MK-1006 40 mg film coated tablets
|
MK-1006 80 mg DFC
n=12 participants at risk
Participants received a single dose of four MK-1006 20 mg dry filled capsules
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12
|
8.3%
1/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
8.3%
1/12
|
|
General disorders
Chest Pain
|
0.00%
0/12
|
8.3%
1/12
|
|
General disorders
Infusion Site Haematoma
|
0.00%
0/12
|
8.3%
1/12
|
|
General disorders
Infusion Site Inflammation
|
0.00%
0/12
|
8.3%
1/12
|
|
General disorders
Infusion Site Pain
|
0.00%
0/12
|
8.3%
1/12
|
|
General disorders
Vessel Puncture Site Haematoma
|
16.7%
2/12
|
0.00%
0/12
|
|
Immune system disorders
Hypersensitivity
|
8.3%
1/12
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/12
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.7%
2/12
|
16.7%
2/12
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/12
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.3%
1/12
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
8.3%
1/12
|
16.7%
2/12
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12
|
8.3%
1/12
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
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 study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER