InteractionPhase 1NCT03498170
The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants
A Phase 1 study testing BCT197 and Itraconazole 200 mg in people with Interaction, run by Mereo BioPharma at 1 site in United States.
Trial summary
An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Interaction
- What is being tested?
- BCT197 and Itraconazole 200 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 9 May 2018
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male participants.
- Non-smokers (including e-cigarettes).
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Willing to use highly effective barrier contraception methods.
- Male participants must not donate sperm during the study.
Who cannot join
- Any participants with pre-existing active skin disease.
- Laboratory values at screening which are deemed to be clinically significant.
- Participants with abnormal liver function tests.
- 12 Lead ECG with QTcF >450 msec.
- Allergy to any of BCT197 excipients.
- Known hypersensitivity or intolerance to itraconazole.
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- Taking medications known to cause QTc prolongation.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Any clinically significant illness within 30 days prior to study drug administration.
- Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
inVentiv Health Clinical Research Services LLC
Miami, Florida, 33136
About this study
Official title: An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants
An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.
Read the detailed description
This will be an open label study conducted in healthy male participants at a single centre. Each participant will participate in a screening visit and 2 study periods. At the first study period, all participants will receive a single dose of BCT197 and at study period 2, all participants will receive 14 daily doses of itraconazole and a single dose of BCT197.
- Conditions
- Interaction
- Being tested
- BCT197, Itraconazole 200 mg
- Keywords
- Healthy Male Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCT197Drug
Also called Acumapimod
Single dose of BCT197
Itraconazole 200 mgDrug
Also called Sporanox
Single dose of itraconazole
| Study group | Role | What they receive |
|---|---|---|
| Period 1 and Period 2 | Other | Period 1 - BCT197 14mg on Day 1
Period 2 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7 Receives: Drug: BCT197; Drug: Itraconazole 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole.
Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1.
Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.
Measured: Pre-dose to Day 15
Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of itraconazole.
Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1.
Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.
Measured: Pre-dose to Day 15
Secondary outcomes (1)
The number of adverse events during administration of BCT197 alone and in the presence of itraconazole.
Measured: Day 1 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start19 Mar 2018
- Primary completion3 May 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mereo BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Parkin, PhD FRCP, Study director, Mereo BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498170
- Sponsor's protocol ID
- MBCT103
- Status last verified
- Apr 2018
- First submitted
- 6 Apr 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT03498170
- Acronym / sponsor ID
- MBCT103
- Conditions
- Interaction
- Keywords
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mereo BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.
Detailed description
This will be an open label study conducted in healthy male participants at a single centre. Each participant will participate in a screening visit and 2 study periods. At the first study period, all participants will receive a single dose of BCT197 and at study period 2, all participants will receive 14 daily doses of itraconazole and a single dose of BCT197.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Period 1 and Period 2 | Other | Drug: BCT197, Drug: Itraconazole 200 mgPeriod 1 - BCT197 14mg on Day 1 Period 2 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male participants.
- Non-smokers (including e-cigarettes).
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Willing to use highly effective barrier contraception methods.
- Male participants must not donate sperm during the study.
Key exclusion criteria (10 listed)
- Any participants with pre-existing active skin disease.
- Laboratory values at screening which are deemed to be clinically significant.
- Participants with abnormal liver function tests.
- 12 Lead ECG with QTcF >450 msec.
- Allergy to any of BCT197 excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCT197Also: AcumapimodSingle dose of BCT197 | Drug | Period 1 and Period 2 |
| Itraconazole 200 mgAlso: SporanoxSingle dose of itraconazole | Drug | Period 1 and Period 2 |
Primary outcome
Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole.
Time frame: Pre-dose to Day 15
Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.
Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of itraconazole.
Time frame: Pre-dose to Day 15
Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.
1 secondary outcome
The number of adverse events during administration of BCT197 alone and in the presence of itraconazole.
Time frame: Day 1 to Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Parkin, PhD FRCP study director
Mereo BioPharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCT197 and Itraconazole 200 mg in people with Interaction, run by Mereo BioPharma 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 5 inclusion and 10 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 18 May 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 Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole. (time frame: Pre-dose to Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2018.