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OpenTrials
Completed

NCT Number: NCT04005807

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase I Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BPN-14967

Drug

BPN-14967 oral capsules

Placebo

Drug

Oral capsules

Primary outcomes

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

    Time frame: Up to Day 8

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

    Time frame: Up to Day 8

  3. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 8

  4. Time to maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 8

  5. Terminal elimination rate constant

    Time frame: Up to Day 8

  6. Terminal phase half-life (t1/2)

    Time frame: Up to Day 8

  7. Apparent total body clearance (CL/F)

    Time frame: Up to Day 8

  8. Apparent volume of distribution (Vz/F)

    Time frame: Up to Day 8

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

    Time frame: Up to Day 10

  10. Number of participants with Clinical Laboratory Results Abnormalities

    Time frame: Up to Day 10

  11. Number of participants with Vital Sign Abnormalities

    Time frame: Up to Day 10

  12. Number of participants with Physical Examination Abnormalities

    Time frame: Up to Day 10

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

    Time frame: Up to Day 10

  14. Number of participants with changes in visual acuity

    Time frame: Baseline and Day 10

  15. Number of participants with Ocular Examination Abnormalities

    Time frame: Up to Day 10

  16. Number of participants with changes in color vision

    Time frame: Baseline and Day 10

Sponsors and collaborators

Lead sponsor

Belite Bio, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2019
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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