A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430

NCT ID: NCT02319772

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-04-30

Brief Summary

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2 subjects will receive BCX4430 for 7 days.

Detailed Description

Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics of single, ascending doses of BCX4430 versus placebo in healthy subjects. Up to 6 ascending dose cohorts will be enrolled in a sequential manner. Eight subjects will be treated with a single dose of study drug per dose cohort: 6 subjects per cohort will receive BCX4430, and 2 subjects per cohort will receive matching placebo.

Part 2 of the study will be initiated following review of all available data from Part 1 by an independent Safety Monitoring Committee

Part 2 of the study will evaluate the safety, tolerability, and pharmacokinetics of 7 days of daily dosing with BCX4430 versus placebo in healthy subjects. Up to 4 ascending dose cohorts will be treated in a sequential manner. Ten subjects will be treated with study drug per dose cohort (8 subjects will receive BCX4430 and 2 subjects will receive placebo per cohort). The planned doses and dosing regimens for each of the Part 2 cohorts will be determined based upon data collected during Part 1.

Conditions

Filovirus Infections; Ebola Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BCX4430

BCX4430 administered as an IM injection

Group Type: EXPERIMENTAL

BCX4430

Intervention Type: DRUG

Placebo

Matched placebo administered as an IM injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BCX4430

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Weight ≥ 50 kg (110 lbs) and ≤ 100 kg (220 lbs)

2. Body mass index (BMI) of 19-32 kg/m2

3. Willing to abstain from alcohol consumption for a period of 2 days prior to and during the study

4. Sexually active women of child bearing potential and sexually active men must utilize 2 highly effective contraceptive methods

5. Abstain from caffeinated beverages

6. Normal vital signs at rest

7. Ability to provide written informed consent

Exclusion Criteria

1. Subjects who are study site employees, or immediate family members of a study site or sponsor employee

2. Participation in a clinical research study within the previous 90 days

3. Any medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject

4. Any screening laboratory test with an abnormal result that is grade 1 (mild) or greater

5. Abnormal ECG (defined as any screening or baseline QTc>450 msec, PR > 200 msec, or ventricular and/or atrial premature contractions that are more frequent than occasional, and/or as couplets or higher in grouping

6. An abnormal cardiovascular exam including a confirmed elevated blood pressure at screening (systolic greater than 140, diastolic greater than 90) after 5 minutes of supine rest, tachycardia >100 bpm after 5 minutes of supine rest

7. Family or personal history of sudden death or QT prolongation

8. Use of prescription, over-the-counter (OTC) medications or herbal supplements, with the exception of acetaminophen and non-oral hormonal contraception, for a period of 7 days prior to and during the study

9. Inadequate muscle mass to receive IM injections

10. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse

11. Current smokers or history of smoking within the last 12 months

12. Serious adverse reaction or serious hypersensitivity to any drug

13. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active

14. Donation or loss of greater than 400 mL of blood within the previous 3 months

15. Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1

16. Pregnant or nursing females

17. Male subjects with pregnant female partners

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo Collier, MBChB

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical

Locations

Quotient Clinical

Ruddington, , United Kingdom

Countries

United Kingdom

References

Mathis A, Collins D, Dobo S, Walling DM, Sheridan WP, Taylor R. Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2022 Apr;11(4):467-474. doi: 10.1002/cpdd.1037. Epub 2022 Feb 19.

Reference Type: DERIVED

PMID: 35182042 (View on PubMed)

Other Identifiers

DMID 14-0030

Identifier Type: OTHER

Identifier Source: secondary_id

BCX4430-101

Identifier Type: -

Identifier Source: org_study_id