A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects

Migraine Clinical Trial

Official title:

A Randomized, Open-Label, Crossover Study to Evaluate the PK, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Doses of STS101, DHE Mesylate IM Injection and DHE Mesylate Nasal Spray in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874832
• Other study ID #: STS101-001
• Status: Completed
• Phase: Phase 1
• Start date: September 11, 2018
• Est. completion date: November 7, 2018

Study information

• Verified date: November 2019
• Source: Satsuma Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.

Description:

Phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of STS101 in healthy subjects. Part 1 was designed to identify a dose level of STS101 for administration in Part 2. Subjects in Part 1 received 3 ascending doses of STS101 in a 3-period crossover manner. During Part 2, subjects received the dose of STS101 selected from Part 1, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 3 period crossover manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 7, 2018
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18 to 50 years of age at the time of enrollment.

• Signed the informed consent document.

• Subject judged to be healthy by a qualified physician

Exclusion Criteria:

• Abnormal physical findings of clinical significance at the screening examination

• Significant abnormal laboratory values at the Screening Visit.

• Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Drug:
• Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Locations

Country	Name	City	State
United States	Quotient Sciences Miami Inc.	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Satsuma Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STS101 Dose Selection - Part 1	To select a dose level of STS101 for further evaluation in Part 2	Pre-dose through 48 hours post-dose
Primary	DHE Relative Bioavailability - Part 2	To assess the relative bioavailability of dihydroergotamine following a single dose of STS101 at the dose level selected in Part 1 compared to a single dose of 1 mg DHE administered by intramuscular injection and 2 mg DHE administered as nasal spray	Pre-dose through 48 hours post-dose
Secondary	DHE Area Under the Curve [AUC] - Part 1	To describe the pharmacokinetic profile based on the AUC of dihydroergotamine following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101	Pre-dose through 48 hours post-dose
Secondary	8'OH-DHE Area Under the Curve [AUC] - Part 1	To describe the pharmacokinetic profile based on the AUC of 8'hydroxydihydroergotamine (8'OH-DHE) following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101	Pre-dose through 48 hours post-dose
Secondary	Serious Adverse Events - Parts 1 & 2	To assess the safety profile through examination of serious adverse events of single doses of STS101; 1 mg DHE administered by intramuscular injection, and 2 mg DHE administered as nasal spray	Pre-dose through 48 hours post-dose
Secondary	Treatment-Related Adverse Events - Parts 1 & 2	To assess the safety profile through examination of treatment-related adverse events of single doses of STS101; 1 mg DHE administered by intramuscular injection, and 2 mg DHE administered as nasal spray	Pre-dose through 48 hours post-dose