Healthy
Conditions
Keywords
pharmacokinetics study
Brief summary
Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.
Detailed description
A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.
Interventions
DRUGPG-760564
200 mg capsule, single dose,fasted when dosed, duration is 4 days
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and surgically sterile or post-menopausal (last menstrual period \> 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening; * Who have not used tobacco or nicotine-containing products within the past 3 months; * Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study; * Who have a body mass index (BMI) between 18 and 32 kg/m2, inclusive.
Exclusion criteria
* History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease; * History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease; * History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding; * History of autoimmune disease; * History of immunodeficiency or of unusual susceptibility to infectious diseases; * History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV); * Any history of hypersensitivity or clinically significant allergy to any drug; * Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality; * Family history of sudden death; * History of uveitis or inflammatory ocular disease; * History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding; * History of autoimmune disease; * History of immunodeficiency or of unusual susceptibility to infectious diseases; * History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV); * Any history of hypersensitivity or clinically significant allergy to any drug; * Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality; * Family history of sudden death; * History of uveitis or inflammatory ocular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | over 12 hours | Maximum plasma concentration after a single dose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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 | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | 200 mg PG 760564. Fasted | 200 mg PG 760564. Fed Then Fasted | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Age Continuous | 31.8 years STANDARD_DEVIATION 10 | 31.8 years STANDARD_DEVIATION 10 | 31.8 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Cmax
Maximum plasma concentration after a single dose
Time frame: over 12 hours
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 200 mg PG 760564. Fed Then Fasted | Cmax | 2567.9 ng/mL | Standard Deviation 652.6 |
| 200 mg PG 760564. Fasted | Cmax | 3568.9 ng/mL | Standard Deviation 633.2 |
Comparison: values are Geometric Means and Confidence Intervals are on the Ratio of Fed to Fasted90% CI: [1.1998, 1.6097]