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

NCT04005807 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: BPN-14967-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (16)

• Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration [AUC(0-t)]

  Up to Day 8

• Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]

  Up to Day 8

• Maximum observed plasma concentration (Cmax)

  Up to Day 8

• Time to maximum observed plasma concentration (Tmax)

  Up to Day 8

• Terminal elimination rate constant

  Up to Day 8

• Terminal phase half-life (t1/2)

  Up to Day 8

• Apparent total body clearance (CL/F)

  Up to Day 8

• Apparent volume of distribution (Vz/F)

  Up to Day 8

• Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation

  Up to Day 10

• Number of participants with Clinical Laboratory Results Abnormalities

  Up to Day 10

• Number of participants with Vital Sign Abnormalities

  Up to Day 10

• Number of participants with Physical Examination Abnormalities

  Up to Day 10

• Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities

  Up to Day 10

• Number of participants with changes in visual acuity

  Baseline and Day 10

• Number of participants with Ocular Examination Abnormalities

  Up to Day 10

• Number of participants with changes in color vision

  Baseline and Day 10

Study Arms (5)

Cohort 1 (fasted condition)

EXPERIMENTAL

10 mg BPN-14967 or placebo

Drug: BPN-14967; Drug: Placebo

Cohort 2 (fasted condition)

EXPERIMENTAL

25 mg BPN-14967 or placebo

Drug: BPN-14967; Drug: Placebo

Cohort 3 (fasted condition)

EXPERIMENTAL

50 mg BPN-14967 or placebo

Drug: BPN-14967; Drug: Placebo

Cohort 4 (fed condition)

EXPERIMENTAL

10 mg BPN-14967 or placebo

Drug: BPN-14967; Drug: Placebo

Cohort 5 (high-fat fed condition)

EXPERIMENTAL

10 mg BPN-14967 or placebo

Drug: BPN-14967; Drug: Placebo

Interventions

BPN-14967 DRUG

BPN-14967 oral capsules

Cohort 1 (fasted condition); Cohort 2 (fasted condition); Cohort 3 (fasted condition); Cohort 4 (fed condition); Cohort 5 (high-fat fed condition)

Placebo DRUG

Oral capsules

Cohort 1 (fasted condition); Cohort 2 (fasted condition); Cohort 3 (fasted condition); Cohort 4 (fed condition); Cohort 5 (high-fat fed condition)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Belite Bio, Inc: lead

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

Study Officials

• Konstantin Petrukhin, PhD

  Professor of Ophthalmic Science, Department of Ophthalmology, Columbia University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 2, 2019
• Study Start: July 19, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)