Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers

MannKind

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: TI-Inhalation Powder A; Drug: TI-Inhalation Powder B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01982604

MKC-TI-179

Details and patient eligibility

About

A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.

Enrollment: 38 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis

  • HNVs with a screening blood pressure less than 140/90 mm Hg
  • Subjects who have hypertension controlled with up to 1 medication and who have a blood pressure less than 140/90 mm Hg
  • Note: For subjects with blood pressure at or above 140/90 mm Hg; two additional readings 5 minutes apart are allowed but the last blood pressure reading must be in range
  • Subjects who have hypercholesterolemia controlled with up to 1 medication and who have a low-density lipoprotein value less than 160 mg/dL

• Good venous access for blood draws

• No smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine cotinine testing < 100 ng/mL

• Body mass index (BMI) < 32 kg/m2

• Completion of informed consent form

Exclusion criteria

• Blood donation (500 mL) within the last 8 weeks
• Fasting blood sugar >100 mg/dL
• History of coronary artery disease, peripheral vascular disease, or congestive heart failure
• Allergy to study drug, components of Boost and Boost Plus, or other study material
• Clinically significant active or chronic illness
• History of asthma, COPD, or any other clinically relevant chronic lung disease
• Respiratory tract infection within 4 weeks before screening
• History of drug or alcohol abuse within the past 5 years
• Positive urine drug screen
• Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
• Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism
• History of malignancy within the 5 years before screening (other than basal cell carcinoma)
• History of human immunodeficiency virus (HIV) infection or hepatitis B or C
• Women who are pregnant, lactating, or planning to become pregnant during the clinical study period
• Women of childbearing potential (premenopausal who have not undergone hysterectomy or bilateral tubal ligation, or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile.
• Any subject who, in the opinion of the PI or a designee, appears not to be qualified for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Sequence (Group) 1

Experimental group

Description:

Subjects randomized to Sequence 1 will receive TI in the following sequence: TI-Inhalation Powder A TI-Inhalation Powder B \*30 units (10 units + 20 units)

Treatment:

Drug: TI-Inhalation Powder B

Drug: TI-Inhalation Powder A

Sequence (Group) 2

Experimental group

Description:

Subjects randomized to Sequence 2 will receive TI in the following sequence: TI-Inhalation Powder B TI-Inhalation Powder A \*30 units (10 units + 20 units)

Treatment:

Drug: TI-Inhalation Powder B

Drug: TI-Inhalation Powder A