Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01096160 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002) | PHASE1 | COMPLETED | 40 | — | — | Mar 1, 2010 | Nov 1, 2010 | Aug 12, 2019 | - | — |
Assessment of the number of participants with at least one clinical or laboratory AE in those receiving multiple oral doses of MK-8266. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product.
Assessment of the number of participants receiving MK-8266 who discontinued therapy due to an AE over 10 days of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Days 0-10.
Assessment of the change from baseline in SBP, obtained using a validated, semi-automated oscillometric device. Evaluated for MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA\^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis.
Assessment of HR (beats/min) on Day 10 (24-hours postdose) with MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA\^0-24hrs). Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Baseline HR values are shown in the Baseline Characteristics section for Panels A, B, C, D, E.
| Arm | Type | Description |
|---|---|---|
| Panel A: MK-8266 BID, 1 mg/Placebo | EXPERIMENTAL | MK-8266 1 mg (0.7 mg in the morning \[AM\] + 0.3 mg in the evening \[PM\]), or as matching placebo BID. |
| Panel B: MK-8266 BID, 1.8 mg/Placebo | EXPERIMENTAL | MK-8266 1.8 mg (1 mg in the AM + 0.8 mg in the PM), or as matching placebo BID. |
| Panel C: MK-8266 TID, 1.8 mg/Placebo | EXPERIMENTAL | MK-8266 TID, 1.8 mg (0.6 mg every 6 hours \[q6hr\]), or as matching placebo TID. |
| Panel D: MK-8266 TID, 2.4 mg/Placebo | EXPERIMENTAL | MK-8266 TID (Panel D), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel D was completed prior to initiation of Panel E. |
| Panel E: MK-8266 TID, 2.4 mg/Placebo | EXPERIMENTAL | MK-8266 TID (Panel E), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel E was initiated after completion of Panel D. |
| Name | Type | Description |
|---|---|---|
| MK-8226 BID, 1 mg | DRUG | MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B. |
| MK-8266 BID, 1.8 mg | DRUG | MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C. |
| MK-8266 TID, 1.8 mg | DRUG | MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D. |
| MK-8266 TID, 2.4 mg | DRUG | MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E. |
| Placebo BID (Panel A) | DRUG | Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B. |
| Placebo BID (Panel B) | DRUG | Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C. |
| Placebo TID (Panel C) | DRUG | Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D. |
| Placebo TID (Panel D) | DRUG | Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E. |
| Placebo TID (Panel E) | DRUG | Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D. |
Inclusion Criteria: * Participant is male with essential hypertension (high blood pressure) * Participant is in good general health (with the exception of hypertension) * Participant has a Body Mass Index (BMI) \<= 33 kg/m\^2 at the Screening visit * Participant has a platelet count \>= 150,000 cu/...