Trial Outcomes & Findings for Safety and Tolerability of Odanacatib (0822-059) (NCT NCT01068262)

Last Updated: 2018-08-28

Results Overview

uNTx/Cr is a biomarker of bone resorption. Urine samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4). Fold change from baseline in time weighted average (TWA) of uNTx/Cr on log scale was analyzed via a linear mixed effect model. All analyses were carried out on the log-fold scale and final results were reported on the original percent scale in WAI after back transformation. The conversion used was weighted average inhibition (WAI) = (1-exp \[mean\])\*100, where the mean was the least squares (LS) mean of log-transformed ratio (TWA/baseline) from the above model.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

44 participants

Primary outcome timeframe

Baseline to Week 4

Results posted on

2018-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Males: Odanacatib (Panel A) Healthy male participants randomized to Odanacatib 50 mg tablet administered once weekly (Qw) for 4 consecutive weeks	Healthy Males: Placebo (Panel A) Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.	Healthy Postmenopausal Females: Odanacatib (Panel B) Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks	Healthy Postmenopausal Females: Placebo (Panel B) Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
Overall Study STARTED	23	9	10	2
Overall Study COMPLETED	20	8	9	2
Overall Study NOT COMPLETED	3	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Males: Odanacatib (Panel A) Healthy male participants randomized to Odanacatib 50 mg tablet administered once weekly (Qw) for 4 consecutive weeks	Healthy Males: Placebo (Panel A) Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.	Healthy Postmenopausal Females: Odanacatib (Panel B) Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
Overall Study Adverse Event	2	0	1
Overall Study Protocol Violation	1	0	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Safety and Tolerability of Odanacatib (0822-059)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Males: Odanacatib (Panel A) n=23 Participants Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks	Healthy Males: Placebo (Panel A) n=9 Participants Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.	Healthy Postmenopausal Females: Odanacatib (Panel B) n=10 Participants Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks	Healthy Postmenopausal Females: Placebo (Panel B) n=2 Participants Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks	Total n=44 Participants Total of all reporting groups
Age, Continuous	58.35 years STANDARD_DEVIATION 6.11 • n=5 Participants	56.44 years STANDARD_DEVIATION 6.60 • n=7 Participants	57.50 years STANDARD_DEVIATION 7.59 • n=5 Participants	65.00 years STANDARD_DEVIATION 14.14 • n=4 Participants	58.07 years STANDARD_DEVIATION 6.84 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	32 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 4

Population: The population of male and postmenopausal female participants on Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. The population of male participants on placebo are also included. Postmenopausal females on placebo were not analyzed for WAI due to there being too few participants in this group (N=2).

Outcome measures

Outcome measures
Measure	Odanacatib (MK-0822) in Males (Panel A) n=20 Participants Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks	Placebo in Males (Panel A) n=8 Participants Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks	Odnacatib (MK-0822) in Postmenopausal Females (Panel B) n=9 Participants Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks	Placebo in Postmenopausal Females (Panel B) Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
Weighted Average Inhibition (WAI) of Urine Aminoterminal Crosslinked Telopeptide of Type I Collagen (u-NTx/Cr) After Administration of Odanacatib 50 mg or Placebo Qw for 4 Weeks in Healthy Males and Postmenopausal Females	42.8 Percent inhibition Interval 35.5 to 49.3	-26.4 Percent inhibition Interval -48.9 to -7.3	42.7 Percent inhibition Interval 30.3 to 52.9	—

SECONDARY outcome

Timeframe: Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)