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

Aspeya Switzerland SA

Status and phase: Completed; Phase 1

Conditions: Safety, and Tolerability

Treatments: Drug: DHE 2 mg administered by nasal spray (Migranal®); Combination Product: DHE inhalation powder high dose administered via dry powder inhaler (DPI) device; Drug: DHE injected intravenously (1 mg); Drug: Metoclopramide 10mg; Combination Product: DHE inhalation powder low dose administered via dry powder inhaler (DPI) device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226362

VFC202-102

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

44 participants in 4 patient groups

Treatment A: inhaled DHE low dose

Experimental group

Description:

Low dose of DHE inhalation powder

Treatment:

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

Treatment B: inhaled DHE high dose

Experimental group

Description:

High dose of DHE inhalation powder

Treatment:

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

Treatment C: intravenous DHE

Active Comparator group

Description:

1 mg DHE injected intravenously

Treatment:

Drug: Metoclopramide 10mg

Drug: DHE injected intravenously (1 mg)

Treatment D: intranasal DHE

Active Comparator group

Description:

2 mg DHE nasal spray (Migranal®)

Treatment:

Drug: DHE 2 mg administered by nasal spray (Migranal®)