Trial Outcomes & Findings for A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512) (NCT NCT01323855)

Results Overview

Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

46 participants

Primary outcome timeframe

Pre-dose to 48 hours post-dose

Results posted on

2018-10-02

Participant Flow

Male or female adults with different degrees of renal impairment along with matched healthy adults with normal renal function were selected for this study.

Participant milestones

Participant milestones
Measure	Part 1: Severe Renal Impairment Participants with severe chronic renal impairment (CRI), defined as creatinine clearance of \<30 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Moderate Renal Impairment Participants with moderate CRI defined as creatinine clearance of ≥30 and \<50 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Mild Renal Impairment Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 1: Normal Renal Function Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Normal Renal Function Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Overall Study STARTED	9	9	8	9	11
Overall Study COMPLETED	9	9	8	9	11
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Severe Renal Impairment n=9 Participants Participants with severe CRI, defined as creatinine clearance of \<30 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Moderate Renal Impairment n=9 Participants Participants with moderate CRI defined as creatinine clearance of ≥30 and \<50 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Mild Renal Impairment n=8 Participants Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 1: Normal Renal Function n=9 Participants Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Normal Renal Function n=11 Participants Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Total n=46 Participants Total of all reporting groups
Age, Continuous	59.6 Years STANDARD_DEVIATION 12.4 • n=5 Participants	66.9 Years STANDARD_DEVIATION 7.8 • n=7 Participants	63.3 Years STANDARD_DEVIATION 7.6 • n=5 Participants	59.3 Years STANDARD_DEVIATION 11.3 • n=4 Participants	67.4 Years STANDARD_DEVIATION 4.0 • n=21 Participants	63.5 Years STANDARD_DEVIATION 9.3 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	20 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	26 Participants n=8 Participants

PRIMARY outcome

Timeframe: Pre-dose to 48 hours post-dose

Population: Four participants with severe CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with severe CRI are presented, participants with mild or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure

Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant

Outcome measures

Outcome measures
Measure	Part 1: Severe Renal Impairment n=5 Participants Participants with severe CRI, defined as creatinine clearance of \<30 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Moderate Renal Impairment Participants with moderate CRI defined as creatinine clearance of ≥30 and \<50 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Mild Renal Impairment Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 1: Normal Renal Function n=7 Participants Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Normal Renal Function Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls	160.53 ng.hr/mL Interval 81.13 to 317.62	—	—	135.12 ng.hr/mL Interval 77.83 to 234.56	—

PRIMARY outcome

Timeframe: Pre-dose to 48 hours post-dose

Population: One participant with moderate CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with moderate CRI are presented, participants with mild or severe CRI or their corresponding healthy matched controls were not analyzed in this outcome measure

Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant

Outcome measures

Outcome measures
Measure	Part 1: Severe Renal Impairment Participants with severe CRI, defined as creatinine clearance of \<30 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Moderate Renal Impairment n=8 Participants Participants with moderate CRI defined as creatinine clearance of ≥30 and \<50 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Mild Renal Impairment Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 1: Normal Renal Function Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally	Part 2: Normal Renal Function n=5 Participants Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls	—	197.43 ng.hr/mL Interval 99.12 to 393.25	—	—	152.18 ng.hr/mL Interval 67.65 to 342.34

PRIMARY outcome

Timeframe: Pre-dose to 48 hours post-dose

Population: One participant with mild CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with mild CRI are presented, participants with severe or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure

Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant