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Drug InteractionPhase 1NCT03385525

Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074

A Phase 1 study testing BIIB074 and Valproic Acid in people with Drug Interaction, run by Biogen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to evaluate the effect of multiple doses of the UGT inhibitor valproic acid on the single-dose pharmacokinetics of BIIB074. The secondary objectives of this study are to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with the UGT… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Drug Interaction
What is being tested?
BIIB074 and Valproic Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
12 Sep 2017to 13 Oct 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must have a body mass index between 18 and 32 kg/m^2, inclusive.
  • Must be male, postmenopausal female, or surgically sterile female
  • Must be in good health as determined by the Investigator, based on medical history and screening evaluations.

Who cannot join

  • History of any clinically significant cardiac, endocrine, gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator
  • Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
  • History of, or positive test result at Screening for, human immunodeficiency virus (HIV)
  • Treatment with any prescription or over-the-counter oral medication (excluding acetaminophen) within 14 days prior to Day -1 and an unwillingness or inability to refrain from this treatment during study participation, unless specifically permitted elsewhere within this protocol.
  • Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Dallas, Texas, 75247

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074 in Healthy Subjects

The primary objective of this study is to evaluate the effect of multiple doses of the UGT inhibitor valproic acid on the single-dose pharmacokinetics of BIIB074. The secondary objectives of this study are to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with the UGT inhibitor valproic acid and to evaluate the effect of the UGT inhibitor valproic acid on the PK of the M13, M14, and M16 metabolites of BIIB074.

Being tested
BIIB074, Valproic Acid
Keywords
Healthy Volunteer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB074Drug

    Administered as specified in the treatment arm

  • Valproic AcidDrug

    Also called Depakote, Depakene, Stavzor, and Valproic

    Administered as specified in the treatment arm

Study groups in NCT03385525
Study groupRoleWhat they receive
BIIB074 150 mg and Valproic Acid 500 mgExperimentalParticipants will receive BIIB074 in tablet form in 150 mg doses. BIIB074 will be taken once daily (QD) on Days 1-16 after an 8-hour fast. Valproic Acid will be given in capsule form in 500 mg doses on prescription (TID) every 8 hours on Days 8-22. The morning dose on Day 16 will be coadministered with BIIB074 following an 8-hour fast.
Receives: Drug: BIIB074; Drug: Valproic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Concentration (Cmax) of BIIB074

    Measured: Day 1 through Day 8, Day 16 through Day 23

  2. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB074

    Measured: Day 1 through Day 8, Day 16 through Day 23

  3. Area Under the Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB074

    Measured: Day 1 through Day 8, Day 16 through Day 23

  4. Time to Reach Maximum Observed Concentration (Tmax) for BIIB074

    Measured: Day 1 through Day 8, Day 16 through Day 23

  5. Time of Last Measured Serum Concentration (Tlast) of BIIB074

    Measured: Day 1 through Day 8, Day 16 through Day 23

  6. Elimination Half-Life (T 1/2) of BIIB074

    Measured: Day 1 through Day 8, Day 16 through Day 23

  7. Apparent Clearance (CL/F) of BIIB074

    Measured: Day 1 through Day 8, Day 16 through Day 23

  8. Apparent Volume of Distribution (V/F) of BIIB074

    Measured: Day 1 through Day 8, Day 16 through Day 23

Secondary outcomes (12)

  1. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

    Measured: Up to Day 32

  2. Number of Participants with Abnormal Change from Baseline of Electrocardiogram (ECG) up to Day 23

    Measured: Day 1, 3, 8, 13, 16, 18, 23

  3. Number of Participants with Abnormal Change from Baseline of Clinical Laboratory Parameters up to Day 23

    Measured: Day 3, 8, 13, 16, 18, 23

  4. Number of Participants with Abnormal Change from Baseline of Vital Signs up to Day 23

    Measured: Day 1, 3, 8, 13, 16, 18, 23

  5. Cmax of BIIB074 Metabolites M13, M14, and M16

    Measured: Day 1 through Day 8, Day 16 through Day 23

  6. AUCinf of BIIB074 Metabolites M13, M14, and M16

    Measured: Day 1 through Day 8, Day 16 through Day 23

  7. AUClast of BIIB074 Metabolites M13, M14, and M16

    Measured: Day 1 through Day 8, Day 16 through Day 23

  8. Tmax of BIIB074 Metabolites M13, M14, and M16

    Measured: Day 1 through Day 8, Day 16 through Day 23

  9. Tlast of BIIB074 Metabolites M13, M14, and M16

    Measured: Day 1 through Day 8, Day 16 through Day 23

  10. T1/2 of BIIB074 Metabolites M13, M14, and M16

    Measured: Day 1 through Day 8, Day 16 through Day 23

  11. Metabolite-to-Parent Ratio in AUC (MRauc) of BIIB074 Metabolites M13, M14, and M16

    Measured: Day 1 through Day 8, Day 16 through Day 23

  12. Number of Participants with Abnormal Change from Baseline in Columbia Suicide Severity Rating (C-SSRS) scale

    C-SSRS is a suicidal ideation rating used to evaluate suicidality in children ages 12 and up. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent

    Measured: Day 8, 23, and once between Day 29-32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2017
  2. Study start12 Sep 2017
  3. Primary completion13 Oct 2017
  4. Study completion13 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03385525
Sponsor's protocol ID
802HV109
Status last verified
Apr 2018
First submitted
13 Oct 2017
Last updated
20 Apr 2018
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Zhao Y, Kotecha M, Finnigan H, Serenko M, Naik H. Evaluation of the Effect of Uridine Diphosphate-Glucuronosyltransferases (UGT) Inhibition by Valproic Acid on Vixotrigine Pharmacokinetics in Healthy Volunteers. Clin Drug Investig. 2022 Oct;42(10):829-837. doi: 10.1007/s40261-022-01194-y. Epub 2022 Aug 31.

    PubMed 36045316

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIIB074 and Valproic Acid in people with Drug Interaction, run by Biogen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Concentration (Cmax) of BIIB074 (time frame: Day 1 through Day 8, Day 16 through Day 23). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03385525, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.

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