A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects

NCT02288481 | Completed Phase 1

• 1 other identifier: TBA-354-CL-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and tolerability of single oral doses of TBA-354 when administered to healthy adult subjects.

Conditions

Tuberculosis

Keywords

Tuberculosis; TBA-354; Pulmonary Tuberculosis; TB

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study will be the number and severity of treatment emergent adverse events (TEAEs) following single doses of TBA-354 and placebo.

  Day 1, 2, 4, 5, 6, 7, 14

Secondary Outcomes (4)

• Pharmacokinetics of TBA-354 in plasma following single oral doses. Cmax, AUC0-24

  Day 1 (Hour 0, 1, 2, 4, 6, 7, 8, 12, 16), Day 2 (Hour 20, 24, 30, 36, 42), Follow up (Hour 72, 96, 120, 144)

• Effect of food on the Pharmacokinetics parameters of TBA-354 in plasma following an intermediate single oral dose. Cmax, AUC0-24

  Day 1 (Hour 0, 1, 2, 4, 6, 7, 8, 12, 16), Day 2 (Hour 20, 24, 30, 36, 42), Follow up (Hour 72, 96, 120, 144)

• Number of subjects/time points with abnormal findings in safety electrocardiogram

  Screening; Day 1 (Hour 0, 1, 2, 4, 6, 8, 12, 16); Day 2 Hour 20, 24, 30, 36 and 48; Follow up Hour 144

• Placebo-corrected safety electrocardiogram Change-from-baseline heart rate

  Screening; Day 1 (Hour 0, 1, 2, 4, 6, 8, 12, 16); Day 2 Hour 20, 24, 30, 36 and 48; Follow up Hour 144

Study Arms (12)

Cohort 1 10 mg TBA-354

EXPERIMENTAL

Drug: TBA-354

Cohort 1 placebo

PLACEBO COMPARATOR

Placebo Suspension

Other: Placebo

Cohort 2 25 mg TBA-354

EXPERIMENTAL

Drug: TBA-354

Cohort 2 placebo

PLACEBO COMPARATOR

Placebo Suspension

Other: Placebo

Cohort 3 60 mg TBA-354

EXPERIMENTAL

Drug: TBA-354

Cohort 3 placebo

PLACEBO COMPARATOR

Placebo Suspension

Other: Placebo

Cohort 4 150 mg TBA-354

EXPERIMENTAL

Drug: TBA-354

Cohort 4 placebo

PLACEBO COMPARATOR

Placebo Suspension

Other: Placebo

Cohort 5 400 mg TBA-354

EXPERIMENTAL

Drug: TBA-354

Cohort 5 placebo

PLACEBO COMPARATOR

Placebo Suspension

Other: Placebo

Cohort 6 1000 mg TBA-354

EXPERIMENTAL

Drug: TBA-354

Cohort 6 placebo

PLACEBO COMPARATOR

Placebo Suspension

Other: Placebo

Interventions

TBA-354 DRUG

TBA-354 supplied as a 20 mg /mL suspension and matching placebo suspension for oral administration.

Cohort 1 10 mg TBA-354; Cohort 2 25 mg TBA-354; Cohort 3 60 mg TBA-354; Cohort 4 150 mg TBA-354; Cohort 5 400 mg TBA-354; Cohort 6 1000 mg TBA-354

Placebo OTHER

Placebo Suspension

Cohort 1 placebo; Cohort 2 placebo; Cohort 3 placebo; Cohort 4 placebo; Cohort 5 placebo; Cohort 6 placebo

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Healthy adult male and females of non-childbearing potential, 19 to 50 years of age (inclusive) at the time of screening.
• Body mass index (BMI) ≥ 18.5 and ≤ 32.0 (kg/m2) and a body weight of no less than 50 kg.
• Medically healthy with no clinically significant screening results (e.g., laboratory profiles, medical histories, vital signs, electrocardiograms (ECGs), physical examination) as deemed by the Principal Investigator.
• No use of tobacco or nicotine containing products (including smoking cessation products), for a minimum of 6 months prior to dosing.
• Females of non-childbearing potential have undergone one of the following sterilization procedures at least 6 months prior to dosing:
• i. Hysteroscopic sterilization
• ii. Bilateral tubal ligation or bilateral salpingectomy
• iii. Hysterectomy
• iv. Bilateral oophorectomy
• v. or be postmenopausal with amenorrhea for at least 1 year prior to the first dose with serumfollicle-stimulating hormone (FSH) levels consistent with postmenopausal status at screening.
• Non-vasectomized males (or males vasectomized less than 120 days prior to study start), must agree to the following during study participation and for 90 days following the last administration of study drug:
• use a condom with spermicide while engaging in sexual activity or be sexually abstinent
• not donate sperm during this time.
• In the event the sexual partner is surgically sterile, use of a condom with spermicide is not necessary. None of the restrictions listed above are required for vasectomized males whose procedure was performed more than 120 days prior to study start.
• Subject understands study procedures and provides written informed consent for the trial.

Sponsors & Collaborators

• Global Alliance for TB Drug Development: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary

Interventions

TBA-354

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Gartner, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 11, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

US (1)