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A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults

NCT ID: NCT07226362

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-09

Study Completion Date

2025-10-02

Brief Summary

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A Phase 1 clinical trial to evaluate the pharmacokinetics, relative bioavailability, safety and tolerability of DHE inhalation powder delivered by dry powder inhaler, DHE IV, and DHE nasal spray.

Detailed Description

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This is an open-label, randomized, 4-treatment, 4-period crossover study to evaluate the PK, relative BA, safety, and tolerability of single doses of study medication in healthy adult subjects.

Following screening, eligible subjects will be enrolled and randomized to one of the 4 treatment sequences. Subjects will receive single doses of DHE inhalation powder (low dose and high dose), DHE IV (1 mg) and DHE nasal spray (2 mg).

Subjects will be administered one treatment in each period according to their assigned sequence. Each subject will receive all 4 treatments in the study.

During each treatment period subjects will remain in the clinical research unit for 3 days, until completion of the 48-hour post-dose assessments.

Subjects will return for their next treatment period after at least 7 days washout after the administration of their previous treatment until all periods have been completed in their sequence.

A follow-up will be conducted on Day 7 after the last dose in the study to assess safety.

Conditions

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Safety, and Tolerability

Keywords

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Dihydroergotamine mesylate Inhalation powder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Eligible subjects will be enrolled and randomized on Day 1 to one of the 4 treatment sequences composed of 4 periods of the crossover design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

None (open-label)

Study Groups

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Treatment A: inhaled DHE low dose

Low dose of DHE inhalation powder

Group Type EXPERIMENTAL

DHE inhalation powder low dose administered via dry powder inhaler (DPI) device

Intervention Type COMBINATION_PRODUCT

The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder low dose formulation for oral inhalation

Treatment B: inhaled DHE high dose

High dose of DHE inhalation powder

Group Type EXPERIMENTAL

DHE inhalation powder high dose administered via dry powder inhaler (DPI) device

Intervention Type COMBINATION_PRODUCT

The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder high dose formulation for oral inhalation

Treatment C: intravenous DHE

1 mg DHE injected intravenously

Group Type ACTIVE_COMPARATOR

DHE injected intravenously (1 mg)

Intervention Type DRUG

A single dose of DHE injection consists of 1 mg/mL ampoule of DHE solution for slow intravenous administration.

Metoclopramide 10mg

Intervention Type DRUG

To prevent nausea caused by IV administration of DHE, participants will receive antiemetic pre-medication with metoclopramide 10 mg administered by slow intravenous push over 1-2 min, given 5 to 10 minutes prior to IV DHE dosing.

Treatment D: intranasal DHE

2 mg DHE nasal spray (Migranal®)

Group Type ACTIVE_COMPARATOR

DHE 2 mg administered by nasal spray (Migranal®)

Intervention Type DRUG

A single vial of DHE nasal spray (Migranal®) contains 1 mL of 4 mg/mL DHE solution.

Interventions

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DHE inhalation powder low dose administered via dry powder inhaler (DPI) device

The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder low dose formulation for oral inhalation

Intervention Type COMBINATION_PRODUCT

DHE inhalation powder high dose administered via dry powder inhaler (DPI) device

The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder high dose formulation for oral inhalation

Intervention Type COMBINATION_PRODUCT

DHE injected intravenously (1 mg)

A single dose of DHE injection consists of 1 mg/mL ampoule of DHE solution for slow intravenous administration.

Intervention Type DRUG

DHE 2 mg administered by nasal spray (Migranal®)

A single vial of DHE nasal spray (Migranal®) contains 1 mL of 4 mg/mL DHE solution.

Intervention Type DRUG

Metoclopramide 10mg

To prevent nausea caused by IV administration of DHE, participants will receive antiemetic pre-medication with metoclopramide 10 mg administered by slow intravenous push over 1-2 min, given 5 to 10 minutes prior to IV DHE dosing.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must meet all the following criteria to be included in the study:

1. Male or female, ≥ 18 and ≤ 55 years of age, with body mass index (BMI) \>18.5 and \< 32.0 kg/m2
2. Healthy subjects
3. Female subjects of non-childbearing potential or childbearing potential willing to use protocol required methods of contraception
4. Current non-smoker
5. Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion Criteria

* Subjects to whom any of the following applies will be excluded from the study:

1. Positive pregnancy test or lactating female subjects at screening or on Day 1 of each treatment period
2. Clinically significant abnormal laboratory or serology test results
3. History or current diagnosis of uncontrolled or significant cardiac disease
4. Significant risk factors for cardiovascular disease
5. Subject with abnormal lung function at screening
6. History or current diagnosis of lung disease e.g. asthma, COPD
7. Known allergic reactions, hypersensitivity or contraindications to DHE, other ergot-derived products or to any excipient
8. History of drug or alcohol abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aspeya Switzerland SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alliance for Multispecialty research (AMR)

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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VFC202-102

Identifier Type: -

Identifier Source: org_study_id