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Completed

NCT Number: NCT02951221

New Formulation and Food Effect Study of BIIB074

The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Must have a body mass index between 18 and 30 kg/m2, inclusive.
  • Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
  • Ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe.

Key Exclusion Criteria:

  • History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
  • Positive test result at Screening for hepatitis C virus antibody.
  • Positive test result at Screening for hepatitis B virus (defined as positive for hepatitis B surface antigen and/or hepatitis B core antibody).
  • Previous exposure to BIIB074.
  • Consumption of xanthine/caffeine-containing products (e.g., energy drinks, coffee, tea, caffeinated soda) within 48 hours of Day -1 and an unwillingness to refrain from product use during study participation.
  • History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug screen or alcohol breath test at Screening or Day -1, or an unwillingness to refrain from alcohol, or illicit or recreational drugs, during the study.
  • History or evidence of habitual use of tobacco- or nicotine-containing products within 90 days of Screening, or a positive cotinine screen at Screening or Day -1.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

BIIB074 Treatment A

Drug

Lower dose RCF fasted

BIIB074 Treatment B

Drug

Lower dose DCF fasted

BIIB074 Treatment C

Drug

Higher dose DCF fasted

BIIB074 Treatment D

Drug

Higher dose DCF fed

Primary outcomes

  1. PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)

    Time frame: Day 1, 2, 3, 8, 9, 10

  2. PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast)

    Time frame: Day 1, 2, 3, 8, 9, 10

  3. PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞)

    Time frame: Day 1, 2, 3, 8, 9, 10

  4. PK of BIIB074 DCF as assessed by Cmax

    Time frame: Day 1, 2, 3, 8, 9, 10

  5. PK of BIIB074 DCF as assessed by AUClast

    Time frame: Day 1, 2, 3, 8, 9, 10

  6. PK of BIIB074 DCF as assessed by AUC∞

    Time frame: Day 1, 2, 3, 8, 9, 10

Secondary outcomes

  1. Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to Day 18

  2. Number of participants with clinically significant laboratory assessment abnormalities

    Time frame: Up to Day 10

  3. Number of participants with clinically significant vital sign abnormalities

    Time frame: Up to Day 10

  4. Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

    Time frame: Up to Day 10

  5. Number of participants with clinically significant physical examinations abnormalities

    Time frame: Up to Day 10

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1, Open-label Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB074 and to Assess the Effect of Food on BIIB074 Pharmacokinetics in Healthy Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Feb 27, 2017

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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