CompletedPhase 1ACTRN12623000148673
Open-Label, Randomized, Fasted, Single Oral Dose, Crossover Trial to Assess the Relative Bioavailability of FP-045 and its Metabolite AD-835 After Single Doses of FP-045 2 X 75 mg Capsules (Test Drug) Compared to 150 mg Reconstituted FP-045 Drug Substance Liquid Formulation (Reference Drug) in Healthy Male Participants
Sponsor
Foresee Pharmaceuticals Co., Ltd.
Enrollment
8 participants
Start Date
Dec 14, 2022
Study Type
Interventional
Conditions
Summary
Crossover Study to Assess the Relative Bioavailability of FP 045 Capsules vs. Reconstituted Drug Substance in Healthy Male Participants
Eligibility
Sex: MalesMin Age: 18 YearssMax Age: 55 Yearss
Inclusion Criteria5
- Male participants between 18 to 55 years of age inclusive.
- Nonsmoker, ex-smoker, or light smoker who smokes <5 cigarettes/week and agrees to no smoking for 5 days before admission and has a negative urine cotinine test at admission (day -1).
- Participants who are overtly healthy based on assessment of medical history, physical examination, vital signs, ECGs, hematology, chemistry, and urinalysis assessments, serology, and other assessments.
- Body mass index between 18 and 32 kg/m2 inclusive.
- Males with female partners of childbearing potential agree to use a barrier contraceptive (ie, condom) and their female partners agree to use a highly effective method of contraception from Screening through 90 days after the last dose of the study drug. Males will agree to refrain from sperm donations during this time period. Males who are abstinent will not be required to use a contraceptive method unless they become sexually active.
Exclusion Criteria12
- History or presence of any clinically significant neurological, metabolic, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, chronic infections, psychiatric, or genitourinary abnormalities or diseases.
- History of malignant neoplastic disease, except for adequately treated non-melanomatous skin carcinoma.
- Mentally or legally incapacitated, had significant emotional problems at Screening or expected during the conduct of the study, or had a history of a clinically significant psychiatric disorder within 5 years before Screening.
- The participant has had a history of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis.
- The participant has had surgery or trauma with significant blood loss within the last 3 months before the first dose of FP-045.
- The participant has donated more than 1 unit (500 mL) of blood within 4 weeks or plasma within one week before the first dose of FP-045.
- Clinically significant laboratory abnormalities including:
- Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus antibody at Screening.
- Positive screen for drugs with a high potential for abuse.
- The participant exercises extensively (eg, marathon, triathlon, or similar high energy sports).
- A history or presence of any clinically significant endocrinologic abnormality or disease
- Use of prescription medications within 7 days (or within 5 half-lives, whichever is longer) of the first dose of FP-045.
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Interventions
Approximately 8 participants will be enrolled in this study.
Study participants will receive a single 150mg dose of FP-045. FP-045 will be administered once only, orally as two 75mg capsules. Part
Approximately 8 participants will be enrolled in this study. Study participants will receive a single 150mg dose of FP-045. FP-045 will be administered once only, orally as two 75mg capsules. Participants must fast for at least 10 hours prior to administration. Administration will occur under supervision. There will be a 5 day wash out period between treatments (120 hours).
Locations(1)
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ACTRN12623000148673