Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults

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Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: BPN-14967

Study type: Interventional

Funder types: Industry

Identifiers

NCT04005807

BPN-14967-001

Details and patient eligibility

About

This is single center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of BPN-14967 in healthy adult subjects.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• The subject is male or female (not of childbearing potential), 18 to 65 years of age, inclusive, at screening.
• The subject voluntarily consents to participate in this study and
• provides written informed consent before the start of any study-specific procedures.
• The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
• Female subjects must be of non-childbearing potential (defined as surgically sterile [i.e., had a bilateral tubal ligation, hysterectomy, or
• bilateral oophorectomy at least 6 months before the dose of study drug] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening).
• Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or agree to use a condom with spermicide when sexually active with a female partner. Male subjects must also agree to refrain from sperm donation for 90 days after study drug administration.
• The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, at screening and weighs 50 to 100 kg (110-220 pounds), inclusive, at screening and Check-in.
• The subject is considered to be in stable health by the investigator

Exclusion Criteria

• Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
• Any recent viral or bacterial infection.
• Participated in any clinical study in last 6 weeks.
• History of significant drug allergy
• History of significant vision, ocular or retinal disorder.
• Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month.
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations

Other protocol-defined inclusion/exclusion criteria could apply.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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40 participants in 5 patient groups

Cohort 1 (fasted condition)

Experimental group

Description:

10 mg BPN-14967 or placebo

Treatment:

Drug: Placebo

Drug: BPN-14967

Cohort 2 (fasted condition)

Experimental group

Description:

25 mg BPN-14967 or placebo

Treatment:

Drug: Placebo

Drug: BPN-14967

Cohort 3 (fasted condition)

Experimental group

Description:

50 mg BPN-14967 or placebo

Treatment:

Drug: Placebo

Drug: BPN-14967

Cohort 4 (fed condition)

Experimental group

Description:

10 mg BPN-14967 or placebo

Treatment:

Drug: Placebo

Drug: BPN-14967

Cohort 5 (high-fat fed condition)

Experimental group

Description:

10 mg BPN-14967 or placebo

Treatment:

Drug: Placebo

Drug: BPN-14967