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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005807
• Other study ID #: BPN-14967-001
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: June 2021
• Source: Belite Bio, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BPN-14967
BPN-14967 oral capsules
• Placebo
Oral capsules

Locations

Country	Name	City	State
United States	PPD Phase I Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Belite Bio, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]		Up to Day 8
Primary	Maximum observed plasma concentration (Cmax)		Up to Day 8
Primary	Time to maximum observed plasma concentration (Tmax)		Up to Day 8
Primary	Terminal elimination rate constant		Up to Day 8
Primary	Terminal phase half-life (t1/2)		Up to Day 8
Primary	Apparent total body clearance (CL/F)		Up to Day 8
Primary	Apparent volume of distribution (Vz/F)		Up to Day 8
Primary	Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation		Up to Day 10
Primary	Number of participants with Clinical Laboratory Results Abnormalities		Up to Day 10
Primary	Number of participants with Vital Sign Abnormalities		Up to Day 10
Primary	Number of participants with Physical Examination Abnormalities		Up to Day 10
Primary	Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities		Up to Day 10
Primary	Number of participants with changes in visual acuity		Baseline and Day 10
Primary	Number of participants with Ocular Examination Abnormalities		Up to Day 10
Primary	Number of participants with changes in color vision		Baseline and Day 10