Phase 1
Completed N=44
Safety and Tolerability of Odanacatib (0822-059)
Source: ClinicalTrials.gov NCT01068262 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: 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; -26.4; 42.7 Percent inhibition
Summary
This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; -26.4; 42.7 | — |
| SECONDARY Area Under the Curve of Plasma Concentration-time From 0 to 168 Hours (AUC0-168hr) of Odanacatib at Week 4 |
33.9; 37.9 | — |
| SECONDARY Overall Maximum Concentration (Cmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4 |
379; 409 | — |
| SECONDARY Concentration of Odanacatib at 168 Hours (C168hr) in Healthy Male and Postmenopausal Female Participants at Week 4 |
80; 85 | — |
| SECONDARY Overall Time to Maximum Concentration (Tmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4 |
4.0; 6.0 | — |
| SECONDARY Apparent Terminal Half-Life (t1/2) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4 |
89.3; 94.7 | — |
| SECONDARY Number of Participants With At Least One Adverse Event (AE) in the Baseline, Treatment, or Post-Treatment Periods |
8; 5; 7; 2 | — |
| SECONDARY Number of Participants Who Discontinued Study Treatment Due to an AE |
2; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- male subject between the ages of 50 and 75 years; post menopausal female subjects between the ages of 45 and 75 years
- Subject is in good general health
- Subject has no evidence of metabolic bone disorder other than osteopenia or osteoporosis
- Subject is a non-smoker
Exclusion Criteria
- Subject works night shift and is unable to avoid nightshift work during the study
- Subject has had major surgery, donated blood or participated in another investigational study with in the past 4 weeks
- Subject has a history of stroke, chronic seizures, or major neurological disease
- Subject has a history of cancer
- Subject consumes excessive amounts of alcohol or caffeine
Data sourced from ClinicalTrials.gov (NCT01068262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.