Healthy ParticipantsPhase 1NCT06948032
Study of BLU-808 in Healthy Adult Participants
A Phase 1 study testing BLU-808 and Midazolam in people with Healthy Participants, run by Blueprint Medicines Corporation at 1 site in United States.
Trial summary
This is a 3-part study. Parts 1 and 2 are randomized, double-blind, placebo-controlled investigations of single ascending doses (SAD) (Part 1) and multiple ascending doses (MAD) (Part 2) of orally administered BLU-808 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BLU-808 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2024to 21 Jan 2025
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, or vital signs, as deemed by the Principal Investigator (PI) or designee.
- No clinically significant cardiac history as judged by the PI or designee at the screening visit and check-in.
Who cannot join
- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- Participant has history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI, designee, or Sponsor.
- Participant has history or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- Participant has positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Participant has been on a diet incompatible with the on-study diet (that is, unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial), in the opinion of the PI or designee, within the 30 days prior to the first dosing and throughout the study.
- Participant has participated in another clinical study within 30 days prior to the first dosing. The 30-day window will be derived from the date of the last dosing in the previous study to the first dosing of the current study.
- Participant has positive coronavirus disease 2019 (COVID-19) results at first check-in.
- Note: Other protocol-specified inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLU-808 and to Assess the Drug-Drug Interaction With a CYP3A Substrate (Midazolam) and the Effect of Food in Healthy Adult Subjects
This is a 3-part study. Parts 1 and 2 are randomized, double-blind, placebo-controlled investigations of single ascending doses (SAD) (Part 1) and multiple ascending doses (MAD) (Part 2) of orally administered BLU-808 in healthy adult participants. Part 2 will also include an evaluation of the effect of multiple doses of BLU-808 on the single-dose pharmacokinetics (PK) of midazolam. Part 3 is an open-label, 2-sequence, 2-period, food effect (FE) study in healthy adult participants.
- Conditions
- Healthy Participants
- Being tested
- BLU-808, Placebo, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLU-808Drug
BLU-808 will be administered per schedule specified in the arm description.
PlaceboDrug
BLU-808 matching placebo will be administered per schedule specified in the arm description.
MidazolamDrug
Midazolam will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: BLU-808 | Experimental | BLU-808 will be administered orally. Receives: Drug: BLU-808 |
| Part 1: Placebo | Placebo comparator | Matching placebo for BLU-808 will be administered orally. Receives: Drug: Placebo |
| Part 2: BLU-808 | Experimental | BLU-808 will be administered orally. Receives: Drug: BLU-808 |
| Part 2: Placebo | Placebo comparator | Matching placebo for BLU-808 will be administered orally. Receives: Drug: Placebo |
| Part 2: Midazolam Alone Followed by BLU-808 and Midazolam | Experimental | Participants will receive oral midazolam in Period 1. Participants will then receive oral BLU-808 with midazolam in period 2. Receives: Drug: BLU-808; Drug: Midazolam |
| Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and Midazolam | Placebo comparator | Participants will receive oral midazolam in Period 1. Participants will then receive oral matching placebo for BLU-808 with midazolam in period 2. Receives: Drug: Placebo; Drug: Midazolam |
| Part 3: BLU-808 (Treatment D, E) | Experimental | BLU-808 will be administered orally. Receives: Drug: BLU-808 |
| Part 3: BLU-808 (Treatment E, D) | Experimental | BLU-808 will be administered orally. Receives: Drug: BLU-808 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to Day 20
Part 2: Number of Participants With TEAEs
Measured: Up to Day 50
Part 3: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t)
Measured: Up to Day 6
Part 3: Maximum Observed Plasma Concentration (Cmax)
Measured: Up to Day 6
Secondary outcomes (9)
Part 1: AUC0-t
Measured: Up to Day 6
Part 1: Cmax
Measured: Up to Day 6
Part 1: Terminal Elimination Half-life (t1/2)
Measured: Up to Day 6
Part 1: Change From Baseline in QTc (Corrected Value of the Interval Between the Q and T Waves on the Electrocardiogram Tracing)
Measured: Up to Day 6
Parts 1 and 2: Change From Baseline in Serum Tryptase Concentrations
Measured: Up to Day 6
Part 2: AUC0-t
Measured: Up to Day 14
Part 2: Cmax
Measured: Up to Day 14
Part 2: t1/2
Measured: Up to Day 19
Part 3: Number of Participants With TEAEs
Measured: Up to Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2025
- Study start7 Aug 2024
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blueprint Medicines Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948032
- Sponsor's protocol ID
- BLU-808-0101
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 28 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLU-808 and to Assess the Drug-Drug Interaction With a CYP3A Substrate (Midazolam) and the Effect of Food in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06948032
- Acronym / sponsor ID
- BLU-808-0101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Blueprint Medicines CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 28 Apr 2025 (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.
This is a 3-part study. Parts 1 and 2 are randomized, double-blind, placebo-controlled investigations of single ascending doses (SAD) (Part 1) and multiple ascending doses (MAD) (Part 2) of orally administered BLU-808 in healthy adult participants. Part 2 will also include an evaluation of the effect of multiple doses of BLU-808 on the single-dose pharmacokinetics (PK) of midazolam. Part 3 is an open-label, 2-sequence, 2-period, food effect (FE) study in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: BLU-808 | Experimental | Drug: BLU-808BLU-808 will be administered orally. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboMatching placebo for BLU-808 will be administered orally. |
| Part 2: BLU-808 | Experimental | Drug: BLU-808BLU-808 will be administered orally. |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboMatching placebo for BLU-808 will be administered orally. |
| Part 2: Midazolam Alone Followed by BLU-808 and Midazolam | Experimental | Drug: BLU-808, Drug: MidazolamParticipants will receive oral midazolam in Period 1. Participants will then receive oral BLU-808 with midazolam in period 2. |
| Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and Midazolam | Placebo comparator | Drug: Placebo, Drug: MidazolamParticipants will receive oral midazolam in Period 1. Participants will then receive oral matching placebo for BLU-808 with midazolam in period 2. |
| Part 3: BLU-808 (Treatment D, E) | Experimental | Drug: BLU-808BLU-808 will be administered orally. |
| Part 3: BLU-808 (Treatment E, D) | Experimental | Drug: BLU-808BLU-808 will be administered orally. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, or vital signs, as deemed by the Principal Investigator (PI) or designee.
- No clinically significant cardiac history as judged by the PI or designee at the screening visit and check-in.
Key exclusion criteria (8 listed)
- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- Participant has history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI, designee, or Sponsor.
- Participant has history or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- Participant has positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Participant has been on a diet incompatible with the on-study diet (that is, unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial), in the opinion of the PI or designee, within the 30 days prior to the first dosing and throughout the study.
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 |
|---|---|---|
| BLU-808BLU-808 will be administered per schedule specified in the arm description. | Drug | Part 1: BLU-808, Part 2: BLU-808, Part 2: Midazolam Alone Followed by BLU-808 and Midazolam, Part 3: BLU-808 (Treatment D, E), Part 3: BLU-808 (Treatment E, D) |
| PlaceboBLU-808 matching placebo will be administered per schedule specified in the arm description. | Drug | Part 1: Placebo, Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and Midazolam, Part 2: Placebo |
| MidazolamMidazolam will be administered per schedule specified in the arm description. | Drug | Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and Midazolam, Part 2: Midazolam Alone Followed by BLU-808 and Midazolam |
Primary outcome
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 20
Part 2: Number of Participants With TEAEs
Time frame: Up to Day 50
Part 3: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t)
Time frame: Up to Day 6
Part 3: Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 6
9 secondary outcomes
Part 1: AUC0-t
Time frame: Up to Day 6
Part 1: Cmax
Time frame: Up to Day 6
Part 1: Terminal Elimination Half-life (t1/2)
Time frame: Up to Day 6
Part 1: Change From Baseline in QTc (Corrected Value of the Interval Between the Q and T Waves on the Electrocardiogram Tracing)
Time frame: Up to Day 6
Parts 1 and 2: Change From Baseline in Serum Tryptase Concentrations
Time frame: Up to Day 6
Part 2: AUC0-t
Time frame: Up to Day 14
Part 2: Cmax
Time frame: Up to Day 14
Part 2: t1/2
Time frame: Up to Day 19
Part 3: Number of Participants With TEAEs
Time frame: Up to Day 26
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 28 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BLU-808 and Midazolam in people with Healthy Participants, run by Blueprint Medicines Corporation 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 8 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 28 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Day 20). The study lists 4 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 28 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.