Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers (NCT NCT01043094)

NCT ID: NCT01043094

Last Updated: 2012-08-13

Results Overview

Area under the curve from start to elimination for Pitavastatin.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2012-08-13

Participant Flow

Study period was from 23 November 2009 to 07 June 2010 All subjects were seen at a medical clinic

Participant milestones

Measure	Pitavastatin 4mg Renal Impaired Subjects with severe renal impairment (glomerular filtration rate \[GFR\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis	Pitavastatin 4mg Healthy Subjects Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers

Baseline characteristics by cohort

Measure	Pitavastatin 4mg Renal Impaired n=8 Participants Subjects with severe renal impairment (glomerular filtration rate \[GFR\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis	Pitavastatin 4mg Healthy Subjects n=8 Participants Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	54.1 years STANDARD_DEVIATION 15.41 • n=5 Participants	52.0 years STANDARD_DEVIATION 2.62 • n=7 Participants	53.1 years STANDARD_DEVIATION 10.74 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Area under the curve from start to elimination for Pitavastatin.

Outcome measures

Measure	Pitavastatin 4mg Renal Impaired n=8 Participants Subjects with severe renal impairment (glomerular filtration rate \[GFR\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis	Pitavastatin 4mg Healthy Subjects n=8 Participants Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))	175 nanogram hour per milliliter (ng•h/mL) Standard Deviation 39	145 nanogram hour per milliliter (ng•h/mL) Standard Deviation 55

SECONDARY outcome

Timeframe: 3 Days

Outcome measures

Measure	Pitavastatin 4mg Renal Impaired n=8 Participants Subjects with severe renal impairment (glomerular filtration rate \[GFR\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis	Pitavastatin 4mg Healthy Subjects n=8 Participants Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Number of Participants With Treatment Emergent Adverse Events	3 Participants	3 Participants

Adverse Events

Pitavastatin 4mg Renal Impaired

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Pitavastatin 4mg Healthy Subjects

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pitavastatin 4mg Renal Impaired n=8 participants at risk Subjects with severe renal impairment (glomerular filtration rate \[GFR\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis	Pitavastatin 4mg Healthy Subjects n=8 participants at risk Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Gastrointestinal disorders Diarrhea	12.5% 1/8	0.00% 0/8
Gastrointestinal disorders Nausea	12.5% 1/8	0.00% 0/8
Gastrointestinal disorders Vomiting	12.5% 1/8	0.00% 0/8
General disorders Fatigue	12.5% 1/8	0.00% 0/8
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8	12.5% 1/8
Renal and urinary disorders Polyuria	12.5% 1/8	0.00% 0/8

Additional Information

Roger Morgan, MD, FACS

Kowa Research Institute, Inc.

Phone: 919-433-1600

Email: RMorgan@KowaUS.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI not to publish.
• Publication restrictions are in place

Restriction type: OTHER