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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-19

Study Completion Date

2019-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 (fasted condition)

10 mg BPN-14967 or placebo

Group Type EXPERIMENTAL

BPN-14967

Intervention Type DRUG

BPN-14967 oral capsules

Placebo

Intervention Type DRUG

Oral capsules

Cohort 2 (fasted condition)

25 mg BPN-14967 or placebo

Group Type EXPERIMENTAL

BPN-14967

Intervention Type DRUG

BPN-14967 oral capsules

Placebo

Intervention Type DRUG

Oral capsules

Cohort 3 (fasted condition)

50 mg BPN-14967 or placebo

Group Type EXPERIMENTAL

BPN-14967

Intervention Type DRUG

BPN-14967 oral capsules

Placebo

Intervention Type DRUG

Oral capsules

Cohort 4 (fed condition)

10 mg BPN-14967 or placebo

Group Type EXPERIMENTAL

BPN-14967

Intervention Type DRUG

BPN-14967 oral capsules

Placebo

Intervention Type DRUG

Oral capsules

Cohort 5 (high-fat fed condition)

10 mg BPN-14967 or placebo

Group Type EXPERIMENTAL

BPN-14967

Intervention Type DRUG

BPN-14967 oral capsules

Placebo

Intervention Type DRUG

Oral capsules

Interventions

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BPN-14967

BPN-14967 oral capsules

Intervention Type DRUG

Placebo

Oral capsules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes