Trial Outcomes & Findings for Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067) (NCT NCT01512667)

Last Updated: 2018-08-28

Results Overview

For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

Results posted on

2018-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Severe Renal Insufficiency Group Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.	Healthy Matched Control Group Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Overall Study STARTED	13	12
Overall Study Matched Participants	12	12
Overall Study Unmatched Participants	1	0
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Severe Renal Insufficiency Group n=13 Participants Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.	Healthy Matched Control Group n=12 Participants Single-dose administration of odanacatib 50 mg to healthy matched control participants.	Total n=25 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 10.9 • n=99 Participants	55.6 years STANDARD_DEVIATION 10.0 • n=107 Participants	59.4 years STANDARD_DEVIATION 10.9 • n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	6 Participants n=107 Participants	12 Participants n=206 Participants

PRIMARY outcome

Timeframe: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

Population: The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.

Outcome measures

Outcome measures
Measure	Severe Renal Insufficiency Group n=12 Participants Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.	Healthy Matched Control Group n=12 Participants Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose	51.47 μM*hr Interval 38.96 to 67.99	32.12 μM*hr Interval 24.6 to 41.95

SECONDARY outcome

Timeframe: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.

Outcome measures

Outcome measures
Measure	Severe Renal Insufficiency Group n=12 Participants Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.	Healthy Matched Control Group n=12 Participants Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Maximum Concentration (Cmax) of MK-0822 After Single Dose	359.85 nM Interval 300.29 to 431.22	246.09 nM Interval 206.91 to 292.69

SECONDARY outcome

Timeframe: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.

Outcome measures

Outcome measures
Measure	Severe Renal Insufficiency Group n=12 Participants Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.	Healthy Matched Control Group n=12 Participants Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose	18.01 hr Interval 2.0 to 96.23	4.02 hr Interval 2.0 to 96.0

SECONDARY outcome

Timeframe: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.

Outcome measures

Outcome measures
Measure	Severe Renal Insufficiency Group n=12 Participants Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.	Healthy Matched Control Group n=12 Participants Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose	73.9 hr Geometric Coefficient of Variation 25.0	80.0 hr Geometric Coefficient of Variation 20.7

Adverse Events

Severe Renal Insufficiency Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Healthy Matched Control Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Severe Renal Insufficiency Group n=13 participants at risk Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.	Healthy Matched Control Group n=12 participants at risk Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Gastrointestinal disorders Constipation	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	0.00% 0/12 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/13 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	8.3% 1/12 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	0.00% 0/12 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Gastrointestinal disorders Toothache	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	0.00% 0/12 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Infections and infestations Bronchitis	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	0.00% 0/12 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Infections and infestations Urethritis	0.00% 0/13 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	8.3% 1/12 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Eye injury	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	0.00% 0/12 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Fall	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	0.00% 0/12 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Hyperphosphataemia	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	0.00% 0/12 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	8.3% 1/12 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Renal and urinary disorders Haematuria	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	0.00% 0/12 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 1/13 • Number of events 1 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.	0.00% 0/12 • Up to 15 days The safety population consisted of all participants who received at least one dose of the study drug.

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
Publication restrictions are in place

Restriction type: LTE60