Trial Outcomes & Findings for Study to Evaluate Potential Food Effects (NCT NCT00791817)

NCT ID: NCT00791817

Last Updated: 2011-09-07

Results Overview

Maximum plasma concentration after a single dose

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: over 12 hours
• Results posted on: 2011-09-07

Participant Flow

Participant milestones

Measure	200 mg PG 760564. Fed Then Fasted 200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state	200 mg PG 760564. Fasted 200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
1: Single Dose Followed by Week Washout STARTED	5	5
1: Single Dose Followed by Week Washout COMPLETED	5	5
1: Single Dose Followed by Week Washout NOT COMPLETED	0	0
2: Single Dose STARTED	5	5
2: Single Dose COMPLETED	5	5
2: Single Dose NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Potential Food Effects

Baseline characteristics by cohort

Measure	200 mg PG 760564. Fed Then Fasted n=5 Participants 200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state	200 mg PG 760564. Fasted n=5 Participants 200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state	Total n=10 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	31.8 years STANDARD_DEVIATION 10.0 • n=5 Participants	31.8 years STANDARD_DEVIATION 10.0 • n=7 Participants	31.8 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: over 12 hours

Maximum plasma concentration after a single dose

Outcome measures

Measure	200 mg PG 760564. Fed Then Fasted n=10 Participants 200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state	200 mg PG 760564. Fasted n=10 Participants 200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
Cmax	2567.9 ng/mL Standard Deviation 652.6 • Interval 1.2 to 1.61	3568.9 ng/mL Standard Deviation 633.2 • Interval 1.2 to 1.61

Adverse Events

200 mg PG 760564. Fed Then Fasted

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

200 mg PG 760564. Fasted

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	200 mg PG 760564. Fed Then Fasted n=10 participants at risk 200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state	200 mg PG 760564. Fasted n=10 participants at risk 200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
Gastrointestinal disorders heme-positive stool	10.0% 1/10 • Number of events 1	0.00% 0/10

Additional Information

Peter Thomas

Procter & Gamble

Phone: 513.622.4838

Email: thomas.pr@pg.com

Results disclosure agreements

• Principal investigator is a sponsor employee Data, calculations, interpretations, opinions, and recommendations are the property of P\&GP. In the event study results are published in the scientific literature by P\&GP, acknowledgment will be made to the Investigator(s) in the accepted style, as appropriate.
• Publication restrictions are in place

Restriction type: OTHER