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Completed

NCT Number: NCT07226362

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

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.

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Key information

Conditions

Safety, and Tolerability

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alliance for Multispecialty research (AMR)

Knoxville, Tennessee, 37920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must meet all the following criteria to be included in the study:
  • Male or female, ≥ 18 and ≤ 55 years of age, with body mass index (BMI) >18.5 and < 32.0 kg/m2
  • Healthy subjects
  • Female subjects of non-childbearing potential or childbearing potential willing to use protocol required methods of contraception
  • Current non-smoker
  • 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:
  • Positive pregnancy test or lactating female subjects at screening or on Day 1 of each treatment period
  • Clinically significant abnormal laboratory or serology test results
  • History or current diagnosis of uncontrolled or significant cardiac disease
  • Significant risk factors for cardiovascular disease
  • Subject with abnormal lung function at screening
  • History or current diagnosis of lung disease e.g. asthma, COPD
  • Known allergic reactions, hypersensitivity or contraindications to DHE, other ergot-derived products or to any excipient
  • History of drug or alcohol abuse

Treatment and study plan

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

Combination Product

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

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

Combination Product

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

DHE injected intravenously (1 mg)

Drug

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

DHE 2 mg administered by nasal spray (Migranal®)

Drug

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

Metoclopramide 10mg

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.

Primary outcomes

  1. Pharmacokinetics: Area under the curve (AUC 0-t) of DHE

    Time frame: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours

    Area under the concentration-time curve from time zero until the last observed plasma concentration of DHE (AUC 0-t)

  2. Pharmacokinetics: Area under the curve (AUC 0-inf) of DHE

    Time frame: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours

    Area under the concentration-time curve from time zero to infinity (extrapolated) of plasma concentrations of DHE (AUC 0-inf)

  3. Pharmacokinetics: Peak plasma concentration (C max) of DHE

    Time frame: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours

    Maximal observed plasma concentration of DHE (C max)

Secondary outcomes

  1. Pharmacokinetics: Area under the curve (AUC 0-t) of 8'-OH-DHE

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Area under the concentration-time curve from time zero until the last observed plasma concentration of 8'-OH-DHE (AUC 0-t)

  2. Pharmacokinetics: Area under the curve (AUC 0-inf) of 8'-OH-DHE

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Area under the concentration-time curve from time zero to infinity (extrapolated) of plasma concentrations of 8'-OH-DHE (AUC 0-inf)

  3. Pharmacokinetics: Peak plasma concentration (C max) of 8'-OH-DHE

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Maximal plasma observed concentration of 8'-OH-DHE (C max)

  4. Pharmacokinetics: Time of peak maximal concentration (T max) of DHE and 8'-OH-DHE

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Time when the maximal plasma concentration of DHE and 8'-OH-DHE are observed (T max)

  5. Pharmacokinetics: Terminal elimination half-life (T 1/2 el) of DHE and 8'-OH-DHE

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Terminal elimination half-life of plasma concentrations of DHE and 8'-OH-DHE (T 1/2 el)

  6. Pharmacokinetics: Area under the curve (AUC 0-30 min) of DHE

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Area under the concentration-time curve from time zero to 30 min of plasma concentrations of DHE (AUC 0-30min)

  7. Pharmacokinetics: Area under the curve (AUC 0-2 hours) of DHE

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Area under the concentration-time curve from time zero to 2 hours of plasma concentrations of DHE (AUC 0-2 hours)

  8. Pharmacokinetics: Apparent clearance of DHE (CL/F)

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Apparent clearance of DHE (CL/F) for DHE inhalation powder and DHE nasal spray Migranal®

  9. Pharmacokinetics: Clearance of DHE (CL)

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Clearance of DHE for intravenous DHE (CL)

  10. Pharmacokinetics: Apparent volume of distribution of DHE (Vz/F)

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Apparent volume of distribution (Vz/F) during terminal phase of DHE for DHE inhalation powder and DHE nasal spray Migranal®

  11. Pharmacokinetics: Volume of distribution of DHE (Vz)

    Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours

    Volume of distribution (Vz) of DHE intravenous

  12. Safety: Number of participants with adverse events

    Time frame: From the time of signing the informed consent until the last visit on Day 7 after the last treatment period

    Adverse events will be recorded and evaluated for their seriousness, severity and relationship to the study drug

  13. Safety: Blood pressure in mmHg

    Time frame: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods

    The changes from baseline in systolic and diastolic blood pressure will be assessed

  14. Safety: Heart rate in beats/min

    Time frame: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods

    The changes from baseline in heart rate will be assessed

  15. Safety: Respiratory rate in breaths/min

    Time frame: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods

    The changes from baseline in respiratory rate will be assessed

  16. Safety: Oral body temperature in degree Celsius

    Time frame: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods

    The changes from baseline in oral body temperature will be assessed

  17. ECG PR interval in msec

    Time frame: Baseline and post-dose measurements from 10 minutes up to 4 hours for each of the 4 treatment periods

    The changes from baseline in 12-lead ECG PR interval will be assessed

  18. ECG QRS complex in msec

    Time frame: Baseline and post-dose measurements from 10 minutes up to 4 hours for each of the 4 treatment periods

    The changes from baseline in 12-lead ECG QRS complex will be assessed

  19. ECG QT interval in msec

    Time frame: Baseline and post-dose measurements from 10 minutes up to 4 hours for each of the 4 treatment periods

    The changes from baseline in 12-lead ECG QT interval and Fridericia's corrected QT interval will be assessed

  20. Physical examination

    Time frame: At screening, and for each of the 4 treatment periods at baseline, and post-dose at day 2 and day 3

    Physical examination (including oral cavity, nasal cavity and injection site examination) will be performed

  21. Lung function by spirometry : Forced Expiratory Volume in 1 sec in % of predicted normal (FEV1 )

    Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours

    Effect of DHE on lung function will be measured by collecting FEV 1 pre- and post-dose at specified timepoints and will be analyzed by FEV1 < 70 % of predicted normal and/or comparison of pre- and post-dose > 20 % decline in FEV1.

  22. Lung function by spirometry : Forced Vital Capacity (FVC) in liters

    Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours

    Effect of DHE on lung function will be measured by collecting Forced Vital Capacity pre- and post-dose at specified timepoints

  23. Lung function by spirometry : FEV1/FVC ratio

    Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours

    Effect of DHE on lung function will be measured by collecting the FEV1/FVC ratio pre- and post-dose at specified timepoints

  24. Lung function by spirometry : Forced Expiratory Flow 25-75 in %

    Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours

    Effect of DHE on lung function will be measured by collecting the mean Forced expiratory Flow between 25% and 75% of the forced vital capacity pre- and post-dose at specified timepoints

  25. Clinical laboratory tests blood and urine

    Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours

    Change from baseline in clinical laboratory tests (including hematology, biochemistry, coagulation, and urinalysis) will be analyzed at different timepoints

Sponsors and collaborators

Lead sponsor

Aspeya Switzerland SA

Industry

Registry information

Official study title

A Phase-1, Open-label Randomized, 4-treatment, 4-period Crossover Study to Evaluate the Pharmacokinetics, Relative Bioavailability, Safety and Tolerability of Single Doses of Dihydroergotamine Mesylate (DHE) Inhalation Powder, DHE Intravenous (IV), and DHE Nasal Spray in Healthy Adult Subjects.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 10, 2025
Registry last updated
Mar 19, 2026

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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